NCT01959139CompletedPhase 1/2
S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 9 Feb 2024
Brief summary (registry, in English)
This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed pancreatic cancer that has spread to other places in the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, 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. It is not yet known whether combination chemotherapy is more effective with or without pegylated recombinant human hyaluronidase in treating pancreatic cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 126 (actual)
- First submitted
- 30 Sept 2013
- Start date
- 23 Jan 2014
- Primary completion date
- Apr 2019
- Lead sponsor
- SWOG Cancer Research Network
- Diseases
- Pancreatic cancer
- NCT number
- NCT01959139
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 126
- From 23 Jan 2014 to the primary completion date, Apr 2019
- 154 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.
Criteria the registry did not label
- Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases
- Patients must have measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
- Patients must not have had any prior treatment with oxaliplatin or irinotecan within 3 years prior to registration; patients must not have had prior chemotherapy in metastatic setting; prior abdominal radiation therapy is not allowed
- Patients must have a Zubrod performance status of 0-1
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>= 9 g/dL
- Total bilirubin =\< institutional upper limit of normal (IULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =\< 2.5 X IULN in the absence of liver metastases or =\< 5.0 x IULN with liver metastasis
- Serum albumin \>= 3 g/dL
- Serum creatinine =\< ULN within 14 days prior to registration OR calculated creatinine clearance \> 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
- Patients must have international normalized ratio (INR) =\< 1.2 within 14 days prior to registration; patients must not be receiving warfarin for therapeutic use, have history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA) requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate (use within 10 days of registration)
- Patients must not be receiving chronic treatment (equivalent of prednisone \> 10 mg/day) with systemic steroids or other immuno-suppressive agent
- Patients must not have liver disease such a cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Patients must not have active bleeding or a pathological condition that is associated with a high risk of bleeding
- Patients with a known history of human immunodeficiency virus (HIV) must not be on active treatment for HIV
- Patients must have no non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy
- 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
- 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; 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
- Patients must have tumor (paraffin block or slides) available for submission and be willing to submit tumor and blood samples
- Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- Patients planning to enroll in the phase I portion of this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (154)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen Coordinator of this site? Confirm its status | Aberdeen | United States | Unknown status |
| Cancer Care Center at Island Hospital Coordinator of this site? Confirm its status | Anacortes | United States | Unknown status |
| Alaska Breast Care and Surgery LLC Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Alaska Women's Cancer Care Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Katmai Oncology Group Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Anchorage Associates in Radiation Medicine Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Randolph Hospital Coordinator of this site? Confirm its status | Asheboro | United States | Unknown status |
| Sutter Auburn Faith Hospital Coordinator of this site? Confirm its status | Auburn | United States | Unknown status |
| Sutter Cancer Centers Radiation Oncology Services-Auburn Coordinator of this site? Confirm its status | Auburn | United States | Unknown status |
| PeaceHealth Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bellingham | United States | Unknown status |
| Saint Charles Health System Coordinator of this site? Confirm its status | Bend | United States | Unknown status |
| Alta Bates Summit Medical Center-Herrick Campus Coordinator of this site? Confirm its status | Berkeley | United States | Unknown status |
| Illinois CancerCare-Bloomington Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| Saint Joseph Medical Center Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| Saint Luke's Mountain States Tumor Institute Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Parkland Health Center-Bonne Terre Coordinator of this site? Confirm its status | Bonne Terre | United States | Unknown status |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Coordinator of this site? Confirm its status | Burbank | United States | Unknown status |
| Mills - Peninsula Hospitals Coordinator of this site? Confirm its status | Burlingame | United States | Unknown status |
| Cone Health Cancer Center at Alamance Regional Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park Coordinator of this site? Confirm its status | Cameron Park | United States | Unknown status |
| Illinois CancerCare-Canton Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Saint Francis Medical Center Coordinator of this site? Confirm its status | Cape Girardeau | United States | Unknown status |
| Southeast Cancer Center Coordinator of this site? Confirm its status | Cape Girardeau | United States | Unknown status |
| Memorial Hospital of Carbondale Coordinator of this site? Confirm its status | Carbondale | United States | Unknown status |
| Illinois CancerCare-Carthage Coordinator of this site? Confirm its status | Carthage | United States | Unknown status |
| Eden Hospital Medical Center Coordinator of this site? Confirm its status | Castro Valley | United States | Unknown status |
| Centralia Oncology Clinic Coordinator of this site? Confirm its status | Centralia | United States | Unknown status |
| Providence Regional Cancer System-Centralia Coordinator of this site? Confirm its status | Centralia | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Providence Oncology and Hematology Care Southeast Coordinator of this site? Confirm its status | Clackamas | United States | Unknown status |
| Clackamas Radiation Oncology Center Coordinator of this site? Confirm its status | Clackamas | United States | Unknown status |
| Southeastern Medical Oncology Center-Clinton Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| Bay Area Hospital Coordinator of this site? Confirm its status | Coos Bay | United States | Unknown status |
| City of Hope Corona Coordinator of this site? Confirm its status | Corona | United States | Unknown status |
| UC Irvine Health Cancer Center-Newport Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| Sutter Davis Hospital Coordinator of this site? Confirm its status | Davis | United States | Unknown status |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Cancer Care Center of Decatur Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Smilow Cancer Hospital-Derby Care Center Coordinator of this site? Confirm its status | Derby | United States | Unknown status |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Swedish Medical Center-Edmonds Coordinator of this site? Confirm its status | Edmonds | United States | Unknown status |
| Crossroads Cancer Center Coordinator of this site? Confirm its status | Effingham | United States | Unknown status |
| Illinois CancerCare-Eureka Coordinator of this site? Confirm its status | Eureka | United States | Unknown status |
| Providence Regional Cancer Partnership Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Smilow Cancer Hospital Care Center-Fairfield Coordinator of this site? Confirm its status | Fairfield | United States | Unknown status |
| Weisberg Cancer Treatment Center Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Saint Luke's Mountain States Tumor Institute - Fruitland Coordinator of this site? Confirm its status | Fruitland | United States | Unknown status |
| Western Illinois Cancer Treatment Center Coordinator of this site? Confirm its status | Galesburg | United States | Unknown status |
| Illinois CancerCare-Galesburg Coordinator of this site? Confirm its status | Galesburg | United States | Unknown status |
| Wayne Memorial Hospital Coordinator of this site? Confirm its status | Goldsboro | United States | Unknown status |
| Southeastern Medical Oncology Center-Goldsboro Coordinator of this site? Confirm its status | Goldsboro | United States | Unknown status |
| Cone Health Cancer Center Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Medical Oncology and Hematology Group PC-Guilford Coordinator of this site? Confirm its status | Guilford | United States | Unknown status |
| Smilow Cancer Hospital Care Center at Saint Francis Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Margaret R Pardee Memorial Hospital Coordinator of this site? Confirm its status | Hendersonville | United States | Unknown status |
| Hendersonville Hematology and Oncology at Pardee Coordinator of this site? Confirm its status | Hendersonville | United States | Unknown status |
| Centerpoint Medical Center LLC Coordinator of this site? Confirm its status | Independence | United States | Unknown status |
| Swedish Cancer Institute-Issaquah Coordinator of this site? Confirm its status | Issaquah | United States | Unknown status |
| Southeastern Medical Oncology Center-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Capital Region Medical Center-Goldschmidt Cancer Center Coordinator of this site? Confirm its status | Jefferson City | United States | Unknown status |
| Saint Luke's Hospital of Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Research Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Heartland Hematology and Oncology Associates Incorporated Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Kadlec Clinic Hematology and Oncology Coordinator of this site? Confirm its status | Kennewick | United States | Unknown status |
| Illinois CancerCare-Kewanee Clinic Coordinator of this site? Confirm its status | Kewanee | United States | Unknown status |
| Seattle Cancer Care Alliance at EvergreenHealth Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| Providence Regional Cancer System-Lacey Coordinator of this site? Confirm its status | Lacey | United States | Unknown status |
| Saint Luke's East - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Unknown status |
| Minimally Invasive Surgery Hospital Coordinator of this site? Confirm its status | Lenexa | United States | Unknown status |
| Kansas Institute of Medicine Cancer and Blood Center Coordinator of this site? Confirm its status | Lenexa | United States | Unknown status |
| Liberty Radiation Oncology Center Coordinator of this site? Confirm its status | Liberty | United States | Unknown status |
| PeaceHealth Saint John Medical Center Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Los Angeles County-USC Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Illinois CancerCare-Macomb Coordinator of this site? Confirm its status | Macomb | United States | Unknown status |
| Fremont - Rideout Cancer Center Coordinator of this site? Confirm its status | Marysville | United States | Unknown status |
| Cone Heath Cancer Center at Mebane Coordinator of this site? Confirm its status | Mebane | United States | Unknown status |
| Saint Luke's Mountain States Tumor Institute - Meridian Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| Memorial Medical Center Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Palo Alto Medical Foundation-Gynecologic Oncology Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Palo Alto Medical Foundation-Camino Division Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Saint Luke's Mountain States Tumor Institute - Nampa Coordinator of this site? Confirm its status | Nampa | United States | Unknown status |
| Providence Newberg Medical Center Coordinator of this site? Confirm its status | Newberg | United States | Unknown status |
| Smilow Cancer Center/Yale-New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Yale-New Haven Hospital North Haven Medical Center Coordinator of this site? Confirm its status | North Haven | United States | Unknown status |
| Sutter Cancer Research Consortium Coordinator of this site? Confirm its status | Novato | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Smilow Cancer Hospital-Orange Care Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Providence Willamette Falls Medical Center Coordinator of this site? Confirm its status | Oregon City | United States | Unknown status |
| Radiation Oncology of Northern Illinois Coordinator of this site? Confirm its status | Ottawa | United States | Unknown status |
| Illinois CancerCare-Ottawa Clinic Coordinator of this site? Confirm its status | Ottawa | United States | Unknown status |
| Menorah Medical Center Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Saint Luke's South Hospital Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Palo Alto Medical Foundation Health Care Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Illinois CancerCare-Pekin Coordinator of this site? Confirm its status | Pekin | United States | Unknown status |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Coordinator of this site? Confirm its status | Pekin | United States | Unknown status |
| Methodist Medical Center of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Illinois CancerCare-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Illinois CancerCare-Peru Coordinator of this site? Confirm its status | Peru | United States | Unknown status |
| Valley Radiation Oncology Coordinator of this site? Confirm its status | Peru | United States | Unknown status |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Kansas City NCI Community Oncology Research Program Coordinator of this site? Confirm its status | Prairie Village | United States | Unknown status |
| Illinois CancerCare-Princeton Coordinator of this site? Confirm its status | Princeton | United States | Unknown status |
| Annie Penn Memorial Hospital Coordinator of this site? Confirm its status | Reidsville | United States | Unknown status |
| Sutter Cancer Centers Radiation Oncology Services-Roseville Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| Sutter Roseville Medical Center Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Sutter General Hospital Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Sainte Genevieve County Memorial Hospital Coordinator of this site? Confirm its status | Sainte Genevieve | United States | Unknown status |
| Heartland Regional Medical Center Coordinator of this site? Confirm its status | Saint Joseph | United States | Unknown status |
| California Pacific Medical Center-Pacific Campus Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Palo Alto Medical Foundation-Santa Cruz Coordinator of this site? Confirm its status | Santa Cruz | United States | Unknown status |
| Sutter Pacific Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Pacific Gynecology Specialists Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Swedish Medical Center-Ballard Campus Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Swedish Medical Center-First Hill Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Group Health Cooperative-Seattle Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Minor and James Medical PLLC Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Providence Regional Cancer System-Shelton Coordinator of this site? Confirm its status | Shelton | United States | Unknown status |
| Rockwood Cancer Treatment Center-DHEC-Downtown Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Rockwood Clinic Cancer Treatment Center-Valley Coordinator of this site? Confirm its status | Spokane Valley | United States | Unknown status |
| Southern Illinois University School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Central Illinois Hematology Oncology Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Memorial Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Missouri Baptist Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Missouri Baptist Sullivan Hospital Coordinator of this site? Confirm its status | Sullivan | United States | Unknown status |
| Palo Alto Medical Foundation-Sunnyvale Coordinator of this site? Confirm its status | Sunnyvale | United States | Unknown status |
| Missouri Baptist Outpatient Center-Sunset Hills Coordinator of this site? Confirm its status | Sunset Hills | United States | Unknown status |
| Cancer Care Specialists of Illinois-Swansea Coordinator of this site? Confirm its status | Swansea | United States | Unknown status |
| Charlotte Hungerford Hospital Center for Cancer Care Coordinator of this site? Confirm its status | Torrington | United States | Unknown status |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Coordinator of this site? Confirm its status | Truckee | United States | Unknown status |
| Smilow Cancer Hospital Care Center-Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Unknown status |
| University of Arizona Cancer Center-North Campus Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| The University of Arizona Medical Center-University Campus Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Saint Luke's Mountain States Tumor Institute-Twin Falls Coordinator of this site? Confirm its status | Twin Falls | United States | Unknown status |
| Sutter Cancer Centers Radiation Oncology Services-Vacaville Coordinator of this site? Confirm its status | Vacaville | United States | Unknown status |
| Sutter Solano Medical Center/Cancer Center Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| PeaceHealth Southwest Medical Center Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| Providence Saint Mary Regional Cancer Center Coordinator of this site? Confirm its status | Walla Walla | United States | Unknown status |
| Smilow Cancer Hospital-Waterbury Care Center Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| City of Hope West Covina Coordinator of this site? Confirm its status | West Covina | United States | Unknown status |
| Southeastern Medical Oncology Center-Wilson Coordinator of this site? Confirm its status | Wilson | United States | Unknown status |
| Providence Regional Cancer System-Yelm Coordinator of this site? Confirm its status | Yelm | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.