Sign in

NCT02713386CompletedPhase 1/2

Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase I/II Study of Ruxolitinib With Front-Line Neoadjuvant and Post-Surgical Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This phase I/II trial studies the side effects and the best dose of ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how well they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel and carboplatin alone.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
147 (actual)
First submitted
15 Mar 2016
Start date
14 Nov 2016
Primary completion date
30 Sept 2021
Lead sponsor
NRG Oncology
NCT number
NCT02713386

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 147
  • From 14 Nov 2016 to the primary completion date, 30 Sept 2021
  • 110 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.

Prior treatment

  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last three years are excluded; patients may have received prior adjuvant chemotherapy and radiotherapy for localized breast cancer, provided that it was completed more than 2 years prior to registration, the patient remains free of recurrent or metastatic disease and hormonal therapy has been discontinued
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
  • Patients who are not candidates for major abdominal surgery due to known medical comorbidities
  • Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy)
  • Receipt of an investigational study drug for any indication within 30 days or 5 half-lives (whichever is longer) prior to day 1 of protocol therapy

Other illness

  • Patients with suspected non-gynecologic malignancy, such as gastrointestinal
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years (2 years for breast cancer); patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions
  • Severe, active co-morbidity defined as follows:
    • Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment
    • Known brain or central nervous system metastases or history of uncontrolled seizures
    • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)
    • Partial or complete gastrointestinal obstruction
  • Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol
  • Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection or known history of tuberculosis; (This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive)

Lab values

  • Patients who are pregnant or nursing; the effects of ruxolitinib on the developing human fetus are unknown; for this reason, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a screening negative serum or urine pregnancy test within 14 days of registration; a second pregnancy test must be done within 24 hours prior to the start of the first cycle of study treatment; women must not be breastfeeding
    • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception
    • Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL

Other

  • Patients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma
  • Patients who are unwilling to be transfused with blood components
  • Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

Who the study is looking for

  • Patients must have clinically and radiographically suspected and previously untreated International Federation of Gynecologic and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation
  • Institutional confirmation of Mullerian epithelial adenocarcinoma on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy; (for phase II of the study formalin-fixed paraffin-embedded \[FFPE\] tissue should be available for laboratory analysis); patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these
  • All patients must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
  • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 28 days prior to registration
    • Radiographic imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease
    • Further protocol-specific assessments
  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0, 1, or 2 within 28 days prior to registration
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced by granulocyte colony stimulating factors (within 14 days prior to registration)
  • Platelets greater than or equal to 100,000/mcl (within 14 days prior to registration)
  • Hemoglobin greater than 9.0 mg/dl (transfusions are permitted to achieve baseline hemoglobin level) (within 14 days prior to registration)
  • Estimated creatinine clearance (CrCl) \>= 50 mL/min according to the Cockcroft-Gault formula (within 14 days prior to registration)
  • Bilirubin =\< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 14 days prior to registration)
  • Alkaline phosphatase =\< 2.5 x ULN (within 14 days prior to registration)
  • Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Ability to swallow and retain oral medication
  • The patient must provide study-specific informed consent prior to study entry
  • BRCA testing results (i.e., comprehensive BRCA1 and BRCA2 sequencing, including assessment of gene rearrangements) must be submitted for all patients enrolled to Amendment 7 and subsequent amendments; BRCA testing results are optional for all patients enrolled prior to Amendment 7; due to the long acceptance of germline BRCA testing through Myriad, Myriad testing reports will be accepted without additional documentation; if testing for germline BRCA is done by other organizations, in addition to the testing report, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) detailing the laboratory results is required; please retain a copy of all reports (positive, variants of unknown significance \[VUS\], or negative)

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

Full criteria on ClinicalTrials.gov

Sites (110)

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

SiteCityCountrySite status
University of New Mexico Cancer Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Southwest Gynecologic Oncology Associates Inc
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Northside Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Sutter Auburn Faith Hospital
Coordinator of this site? Confirm its status
AuburnUnited StatesUnknown status
Augusta University Medical Center
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Mary Bird Perkins Cancer Center
Coordinator of this site? Confirm its status
Baton RougeUnited StatesUnknown status
Woman's Hospital
Coordinator of this site? Confirm its status
Baton RougeUnited StatesUnknown status
UHHS-Chagrin Highlands Medical Center
Coordinator of this site? Confirm its status
BeachwoodUnited StatesUnknown status
Henry Ford Cancer Institute-Downriver
Coordinator of this site? Confirm its status
BrownstownUnited StatesUnknown status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status
Fairview Ridges Hospital
Coordinator of this site? Confirm its status
BurnsvilleUnited StatesUnknown status
Miami Valley Hospital South
Coordinator of this site? Confirm its status
CentervilleUnited StatesUnknown status
Geauga Hospital
Coordinator of this site? Confirm its status
ChardonUnited StatesUnknown status
West Virginia University Charleston Division
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
University of Virginia Cancer Center
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
John H Stroger Jr Hospital of Cook County
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Case Western Reserve University
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Cleveland Clinic Cancer Center/Fairview Hospital
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Cleveland Clinic Foundation
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
MetroHealth Medical Center
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Riverside Methodist Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
The Mark H Zangmeister Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Mercy Hospital
Coordinator of this site? Confirm its status
Coon RapidsUnited StatesUnknown status
Women's Cancer Care-Covington
Coordinator of this site? Confirm its status
CovingtonUnited StatesUnknown status
Parkland Memorial Hospital
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Danbury Hospital
Coordinator of this site? Confirm its status
DanburyUnited StatesUnknown status
Carle at The Riverfront
Coordinator of this site? Confirm its status
DanvilleUnited StatesUnknown status
Henry Ford Medical Center-Fairlane
Coordinator of this site? Confirm its status
DearbornUnited StatesUnknown status
Henry Ford Hospital
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
Coordinator of this site? Confirm its status
Eau ClaireUnited StatesUnknown status
Fairview Southdale Hospital
Coordinator of this site? Confirm its status
EdinaUnited StatesUnknown status
Carle Physician Group-Effingham
Coordinator of this site? Confirm its status
EffinghamUnited StatesUnknown status
Parkview Regional Medical Center
Coordinator of this site? Confirm its status
Fort WayneUnited StatesUnknown status
CTCA at Western Regional Medical Center
Coordinator of this site? Confirm its status
GoodyearUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesUnknown status
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
South Carolina Cancer Specialists PC
Coordinator of this site? Confirm its status
Hilton Head IslandUnited StatesUnknown status
Ascension Saint Vincent Indianapolis Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
University of Iowa/Holden Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
West Michigan Cancer Center
Coordinator of this site? Confirm its status
KalamazooUnited StatesUnknown status
Northwestern Medicine Lake Forest Hospital
Coordinator of this site? Confirm its status
Lake ForestUnited StatesUnknown status
Women's Cancer Center of Nevada
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
UCLA / Jonsson Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Norton Hospital Pavilion and Medical Campus
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Norton Suburban Hospital and Medical Campus
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
Fairview Clinics and Surgery Center Maple Grove
Coordinator of this site? Confirm its status
Maple GroveUnited StatesUnknown status
Marshfield Medical Center-Marshfield
Coordinator of this site? Confirm its status
MarshfieldUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
Coordinator of this site? Confirm its status
MattoonUnited StatesUnknown status
Hillcrest Hospital Cancer Center
Coordinator of this site? Confirm its status
Mayfield HeightsUnited StatesUnknown status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Abbott-Northwestern Hospital
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Marshfield Medical Center - Minocqua
Coordinator of this site? Confirm its status
MinocquaUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Helen F Graham Cancer Center
Coordinator of this site? Confirm its status
NewarkUnited StatesUnknown status
Christiana Care Health System-Christiana Hospital
Coordinator of this site? Confirm its status
NewarkUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
UC Comprehensive Cancer Center at Silver Cross
Coordinator of this site? Confirm its status
New LenoxUnited StatesUnknown status
Ochsner Medical Center Jefferson
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Norwalk Hospital
Coordinator of this site? Confirm its status
NorwalkUnited StatesUnknown status
Henry Ford Medical Center-Columbus
Coordinator of this site? Confirm its status
NoviUnited StatesUnknown status
University of Oklahoma Health Sciences Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Nebraska Methodist Hospital
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
University of Chicago Medicine-Orland Park
Coordinator of this site? Confirm its status
Orland ParkUnited StatesUnknown status
Pennsylvania Hospital
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pennsylvania/Abramson Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Cancer Institute (UPCI)
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Legacy Good Samaritan Hospital and Medical Center
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Women and Infants Hospital
Coordinator of this site? Confirm its status
ProvidenceUnited StatesUnknown status
Beebe Health Campus
Coordinator of this site? Confirm its status
Rehoboth BeachUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
Coordinator of this site? Confirm its status
Rice LakeUnited StatesUnknown status
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Coordinator of this site? Confirm its status
Rio RanchoUnited StatesUnknown status
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Sutter Roseville Medical Center
Coordinator of this site? Confirm its status
RosevilleUnited StatesUnknown status
Sutter Medical Center Sacramento
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
Coordinator of this site? Confirm its status
Saint Louis ParkUnited StatesUnknown status
United Hospital
Coordinator of this site? Confirm its status
Saint PaulUnited StatesUnknown status
Regions Hospital
Coordinator of this site? Confirm its status
Saint PaulUnited StatesUnknown status
California Pacific Medical Center-Pacific Campus
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Sarasota Memorial Hospital
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Summit Cancer Care-Candler
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Memorial Health University Medical Center
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
University of Washington Medical Center - Montlake
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Center
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Robert Wood Johnson University Hospital Somerset
Coordinator of this site? Confirm its status
SomervilleUnited StatesUnknown status
CoxHealth South Hospital
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Mercy Hospital Springfield
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
Coordinator of this site? Confirm its status
Stevens PointUnited StatesUnknown status
Barnes-Jewish Hospital
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Munson Medical Center
Coordinator of this site? Confirm its status
Traverse CityUnited StatesUnknown status
Legacy Meridian Park Hospital
Coordinator of this site? Confirm its status
TualatinUnited StatesUnknown status
Carle Cancer Center
Coordinator of this site? Confirm its status
UrbanaUnited StatesUnknown status
The Carle Foundation Hospital
Coordinator of this site? Confirm its status
UrbanaUnited StatesUnknown status
Legacy Salmon Creek Hospital
Coordinator of this site? Confirm its status
VancouverUnited StatesUnknown status
Marshfield Clinic-Wausau Center
Coordinator of this site? Confirm its status
WausauUnited StatesUnknown status
Henry Ford West Bloomfield Hospital
Coordinator of this site? Confirm its status
West BloomfieldUnited StatesUnknown status
UHHS-Westlake Medical Center
Coordinator of this site? Confirm its status
WestlakeUnited StatesUnknown status
Marshfield Medical Center - Weston
Coordinator of this site? Confirm its status
WestonUnited StatesUnknown status
Asplundh Cancer Pavilion
Coordinator of this site? Confirm its status
Willow GroveUnited StatesUnknown status
Wake Forest University Health Sciences
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status
Minnesota Oncology Hematology PA-Woodbury
Coordinator of this site? Confirm its status
WoodburyUnited StatesUnknown status
UMass Memorial Medical Center - Memorial Division
Coordinator of this site? Confirm its status
WorcesterUnited StatesUnknown status
Midwestern Regional Medical Center
Coordinator of this site? Confirm its status
ZionUnited StatesUnknown status

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