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NCT01064648Active, not recruitingPhase 1/2

Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma

A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination With Cisplatin and Pemetrexed in Chemonaive Patients With Malignant Pleural Mesothelioma

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
117 (actual)
First submitted
5 Feb 2010
Start date
15 Mar 2010
Primary completion date
1 Jun 2018
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT01064648

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 117
  • From 15 Mar 2010 to the primary completion date, 1 Jun 2018
  • 230 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Patient must have histologically or cytologically confirmed diagnosis of malignant pleural mesothelioma; surgical resection must not be planned
  • Patients must have measurable or non-measurable disease by both RECIST and modified RECIST criteria for pleural tumors as documented by computed tomography (CT) scan; examinations for assessment of measurable disease must have been completed within 28 days prior to registration; examinations for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the RECIST 1.1 and Modified RECIST Baseline Tumor Assessment Form
  • Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for their unresectable malignant pleural mesothelioma; prior systemic chemotherapy or biologic therapy is allowed as neoadjuvant or adjuvant treatment, disease has now recurred, and all systemic treatment was completed \> 6 months prior registration; prior therapy must not have included cediranib
  • Patients may have received prior surgery (e.g., pleurectomy, pleurodeisis) provided at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration; there must be no anticipated need for major surgical procedures during protocol treatment
  • Patients may have received prior radiation therapy provided at least 28 days have elapsed since the last treatment and patients have recovered from all associated toxicities at the time of registration
  • Institutions must seek additional patient consent for the banking and future use of specimens
  • Patient must have Zubrod performance status 0-2
  • Absolute neutrophil count \>= 1,500 mcl
  • Platelets \>= 100,000/ml
  • Hemoglobin \>= 9.0 g/dl (may be reached by transfusion)
  • Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x ULN (if liver metastases are present, SGOT or SGPT must be =\< 5.0 x IULN)
  • Serum creatinine =\< 1.5 x IULN
  • Calculated creatinine clearance \>= 60 mL/min
  • Urine protein must be screened by urine analysis within 28 days prior to registration; patient must not have greater than +1 proteinuria on two consecutive dipsticks taken no less than 7 days apart; however, if the first urinalysis shows no protein, then a repeat urinalysis is not required
  • Patient must have an electrocardiogram (ECG) performed within 42 days prior to registration; patient must not have mean corrected QT (QTc) \> 500 msec (with Bazett's correction) in screening electrocardiogram, or other significant ECG abnormality, New York Heart Association (NYHA) classification III or IV; patient must not require concurrent use of drugs or biologics with proarrhythmic potential
  • Patient must not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
  • Patient must not have had clinically significant hemoptysis, defined as greater than 1 tablespoon of bright red blood, within one year prior to registration; although hemoptysis has not been associated with cediranib, it may be a class effect for anti-angiogenic agents and therefore a risk factor for this experimental agent
  • Patient must be able to swallow oral medications
  • Patients must not have known human immunodeficiency virus (HIV) infection
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (230)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queen's Cancer Center - Pearlridge
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‘AieaUnited StatesUnknown status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
Community Hospital of Anaconda
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AnacondaUnited StatesUnknown status
Cancer Care Center at Island Hospital
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AnacortesUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesUnknown status
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesUnknown status
Michigan Cancer Research Consortium NCORP
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Ann ArborUnited StatesUnknown status
Kaiser Permanente-Deer Valley Medical Center
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AntiochUnited StatesUnknown status
Franciscan Saint Francis Health-Beech Grove
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Beech GroveUnited StatesUnknown status
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesUnknown status
Strecker Cancer Center-Belpre
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BelpreUnited StatesUnknown status
Montana Cancer Consortium NCORP
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BillingsUnited StatesUnknown status
Saint Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Saint Vincent Healthcare
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BillingsUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
OSF Saint Joseph Medical Center
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BloomingtonUnited StatesUnknown status
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesUnknown status
Prisma Health Cancer Institute - Spartanburg
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Boiling SpringsUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Parkland Health Center-Bonne Terre
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Bonne TerreUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Wellmont Medical Associates Oncology and Hematology-Bristol
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BristolUnited StatesUnknown status
Bristol Regional Medical Center
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BristolUnited StatesUnknown status
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesUnknown status
Saint Anne Hospital
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BurienUnited StatesUnknown status
Saint James Community Hospital and Cancer Treatment Center
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ButteUnited StatesUnknown status
Illinois CancerCare-Canton
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CantonUnited StatesUnknown status
Mercy Cancer Center - Cape Girardeau
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Cape GirardeauUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Memorial Hospital of Carbondale
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CarbondaleUnited StatesUnknown status
Illinois CancerCare-Carthage
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CarthageUnited StatesUnknown status
Rocky Mountain Oncology
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CasperUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesUnknown status
Southern Oncology Specialists-Charlotte
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CharlotteUnited StatesUnknown status
Oncology Specialists of Charlotte
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CharlotteUnited StatesUnknown status
Novant Health Carolina Surgical - Randolph
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CharlotteUnited StatesUnknown status
Adena Regional Medical Center
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ChillicotheUnited StatesUnknown status
Oncology Hematology Care Inc-Anderson
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CincinnatiUnited StatesUnknown status
Oncology Hematology Care Inc-Kenwood
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CincinnatiUnited StatesUnknown status
Oncology Hematology Care Inc-Mercy West
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CincinnatiUnited StatesUnknown status
Oncology Hematology Care Inc-Eden Park
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CincinnatiUnited StatesUnknown status
Oncology Hematology Care Inc-Blue Ash
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CincinnatiUnited StatesUnknown status
Clackamas Radiation Oncology Center
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ClackamasUnited StatesUnknown status
Billings Clinic-Cody
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CodyUnited StatesUnknown status
Big Horn Basin Cancer Center
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CodyUnited StatesUnknown status
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesUnknown status
Mount Carmel East Hospital
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ColumbusUnited StatesUnknown status
The Mark H Zangmeister Center
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ColumbusUnited StatesUnknown status
Mount Carmel Health Center West
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ColumbusUnited StatesUnknown status
Columbus NCI Community Oncology Research Program
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ColumbusUnited StatesUnknown status
Columbus Oncology and Hematology Associates Inc
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ColumbusUnited StatesUnknown status
Grant Medical Center
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ColumbusUnited StatesUnknown status
Doctors Hospital
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ColumbusUnited StatesUnknown status
Riverside Methodist Hospital
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ColumbusUnited StatesUnknown status
Oncology Hematology Care Inc-Crestview
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Crestview HillsUnited StatesUnknown status
Danville Regional Medical Center
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DanvilleUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Grandview Hospital
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DaytonUnited StatesUnknown status
Dayton NCI Community Oncology Research Program
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DaytonUnited StatesUnknown status
Good Samaritan Hospital - Dayton
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DaytonUnited StatesUnknown status
Corewell Health Dearborn Hospital
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DearbornUnited StatesUnknown status
Heartland Cancer Research NCORP
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DecaturUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Delaware Radiation Oncology
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DelawareUnited StatesUnknown status
Delaware Health Center-Grady Cancer Center
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DelawareUnited StatesUnknown status
Grady Memorial Hospital
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DelawareUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Prisma Health Cancer Institute - Easley
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EasleyUnited StatesUnknown status
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Illinois CancerCare-Eureka
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EurekaUnited StatesUnknown status
Oncology Hematology Care Inc-Healthplex
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FairfieldUnited StatesUnknown status
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesUnknown status
Blanchard Valley Hospital
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FindlayUnited StatesUnknown status
Genesys Hurley Cancer Institute
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FlintUnited StatesUnknown status
Hurley Medical Center
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FlintUnited StatesUnknown status
Genesys Regional Medical Center-West Flint Campus
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FlintUnited StatesUnknown status
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesUnknown status
Kaiser Permanente-Fremont
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FremontUnited StatesUnknown status
Kaiser Permanente-Fresno
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FresnoUnited StatesUnknown status
Northeast Georgia Medical Center-Gainesville
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GainesvilleUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
Western Illinois Cancer Treatment Center
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GalesburgUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Great Falls Clinic
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Great FallsUnited StatesUnknown status
Wayne Hospital
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Faris
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Eastside
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GreenvilleUnited StatesUnknown status
Prisma Health Greenville Memorial Hospital
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Butternut
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GreenvilleUnited StatesUnknown status
Greenville Health System Cancer Institute-Andrews
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Greer
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GreerUnited StatesUnknown status
Smilow Cancer Hospital Care Center at Saint Francis
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HartfordUnited StatesUnknown status
Saint Peter's Community Hospital
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HelenaUnited StatesUnknown status
Margaret R Pardee Memorial Hospital
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HendersonvilleUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
University of Hawaii Cancer Center
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
Queen's Cancer Center - Kuakini
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc-Liliha
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HonoluluUnited StatesUnknown status
Kaiser Permanente Moanalua Medical Center
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Kuakini Medical Center
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HonoluluUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Novant Health Cancer Institute - Huntersville
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HuntersvilleUnited StatesUnknown status
Southern Oncology Specialists-Huntersville
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HuntersvilleUnited StatesUnknown status
Franciscan Health Indianapolis
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IndianapolisUnited StatesUnknown status
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesUnknown status
Allegiance Health
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JacksonUnited StatesUnknown status
MU Health Care Goldschmidt Cancer Center
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Jefferson CityUnited StatesUnknown status
Wellmont Medical Associates Oncology and Hematology-Johnson City
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Johnson CityUnited StatesUnknown status
Castle Medical Center
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KailuaUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Glacier Oncology PLLC
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KalispellUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesUnknown status
Ballad Health Cancer Care - Kingsport
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KingsportUnited StatesUnknown status
Wellmont Holston Valley Hospital and Medical Center
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KingsportUnited StatesUnknown status
FHCC at EvergreenHealth
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KirklandUnited StatesUnknown status
Fairfield Medical Center
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LancasterUnited StatesUnknown status
University of Michigan Health - Sparrow Lansing
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LansingUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
Wilcox Memorial Hospital and Kauai Medical Clinic
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LihueUnited StatesUnknown status
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesUnknown status
PeaceHealth Saint John Medical Center
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LongviewUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Los Angeles General Medical Center
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Los AngelesUnited StatesUnknown status
Illinois CancerCare-Macomb
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MacombUnited StatesUnknown status
OhioHealth Mansfield Hospital
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MansfieldUnited StatesUnknown status
Marietta Memorial Hospital
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MariettaUnited StatesUnknown status
OhioHealth Marion General Hospital
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MarionUnited StatesUnknown status
Novant Health Cancer Institute - Matthews
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MatthewsUnited StatesUnknown status
Matthews Radiation Oncology Center
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MatthewsUnited StatesUnknown status
Providence Milwaukie Hospital
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MilwaukieUnited StatesUnknown status
Montana Cancer Specialists
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MissoulaUnited StatesUnknown status
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesUnknown status
Community Medical Center
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MissoulaUnited StatesUnknown status
Kaiser Permanente-Modesto
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ModestoUnited StatesUnknown status
Novant Health Cancer Institute - Mooresville
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MooresvilleUnited StatesUnknown status
Knox Community Hospital
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Mount VernonUnited StatesUnknown status
Skagit Valley Hospital
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Mount VernonUnited StatesUnknown status
Newark Radiation Oncology
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NewarkUnited StatesUnknown status
Licking Memorial Hospital
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NewarkUnited StatesUnknown status
Providence Newberg Medical Center
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NewbergUnited StatesUnknown status
Ballad Health Cancer Care - Norton
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NortonUnited StatesUnknown status
Kaiser Permanente-Oakland
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OaklandUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
Radiation Oncology of Northern Illinois
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OttawaUnited StatesUnknown status
Singing River Hospital
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PascagoulaUnited StatesUnknown status
OSF Saint Francis Radiation Oncology at Pekin
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PekinUnited StatesUnknown status
Illinois CancerCare-Pekin
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PekinUnited StatesUnknown status
Illinois CancerCare-Peoria
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PeoriaUnited StatesUnknown status
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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PeoriaUnited StatesUnknown status
OSF Saint Francis Medical Center
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PeoriaUnited StatesUnknown status
Methodist Medical Center of Illinois
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PeoriaUnited StatesUnknown status
Valley Radiation Oncology
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PeruUnited StatesUnknown status
Illinois CancerCare-Peru
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PeruUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesUnknown status
Lake Huron Medical Center
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Port HuronUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
Southern Ohio Medical Center
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PortsmouthUnited StatesUnknown status
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesUnknown status
Harrison HealthPartners Hematology and Oncology-Poulsbo
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PoulsboUnited StatesUnknown status
Illinois CancerCare-Princeton
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PrincetonUnited StatesUnknown status
Kaiser Permanente-Redwood City
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Redwood CityUnited StatesUnknown status
Reid Health
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RichmondUnited StatesUnknown status
Kaiser Permanente-Richmond
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RichmondUnited StatesUnknown status
Highlands Oncology Group - Rogers
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RogersUnited StatesUnknown status
Kaiser Permanente-Roseville
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RosevilleUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Kaiser Permanente Sacramento Medical Center
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SacramentoUnited StatesUnknown status
Kaiser Permanente-South Sacramento
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SacramentoUnited StatesUnknown status
MyMichigan Medical Center Saginaw
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SaginawUnited StatesUnknown status
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesUnknown status
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesUnknown status
Kaiser Permanente-San Francisco
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San FranciscoUnited StatesUnknown status
Kaiser Permanente-Santa Teresa-San Jose
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San JoseUnited StatesUnknown status
Kaiser Permanente San Leandro
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San LeandroUnited StatesUnknown status
Kaiser Permanente-San Rafael
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San RafaelUnited StatesUnknown status
Kaiser Permanente Medical Center - Santa Clara
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Santa ClaraUnited StatesUnknown status
Kaiser Permanente-Santa Rosa
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Santa RosaUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
Harborview Medical Center
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SeattleUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Kaiser Permanente Washington
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SeattleUnited StatesUnknown status
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Minor and James Medical PLLC
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SeattleUnited StatesUnknown status
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesUnknown status
Prisma Health Cancer Institute - Seneca
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SenecaUnited StatesUnknown status
Welch Cancer Center
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SheridanUnited StatesUnknown status
Saint Joseph Medical Center Hematology and Oncology - Silverdale
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SilverdaleUnited StatesUnknown status
Kaiser Permanente-South San Francisco
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South San FranciscoUnited StatesUnknown status
Cancer Care Northwest - Spokane South
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SpokaneUnited StatesUnknown status
Evergreen Hematology and Oncology PS
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SpokaneUnited StatesUnknown status
Rockwood Clinic
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SpokaneUnited StatesUnknown status
Springfield Regional Medical Center
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SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Central Illinois Hematology Oncology Center
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SpringfieldUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Iredell Memorial Hospital
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StatesvilleUnited StatesUnknown status
Missouri Baptist Medical Center
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St LouisUnited StatesUnknown status
Kaiser Permanente-Stockton
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StocktonUnited StatesUnknown status
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesUnknown status
Cotton O'Neil Cancer Center / Stormont Vail Health
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TopekaUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
Kaiser Permanente Medical Center-Vacaville
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VacavilleUnited StatesUnknown status
Kaiser Permanente-Vallejo
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VallejoUnited StatesUnknown status
PeaceHealth Southwest Medical Center
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VancouverUnited StatesUnknown status
Compass Oncology Vancouver
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VancouverUnited StatesUnknown status
Kaiser Permanente-Walnut Creek
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Walnut CreekUnited StatesUnknown status
Henry Ford Health Warren Hospital
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WarrenUnited StatesUnknown status
Wenatchee Valley Hospital and Clinics
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WenatcheeUnited StatesUnknown status
Saint Ann's Hospital
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WestervilleUnited StatesUnknown status
Southeast Clinical Oncology Research Consortium NCORP
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Winston-SalemUnited StatesUnknown status
Greene Memorial Hospital
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XeniaUnited StatesUnknown status
Genesis Healthcare System Cancer Care Center
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ZanesvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.