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
- Diseases
- Ovarian cancer
- 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
Sites (110)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Southwest Gynecologic Oncology Associates Inc Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Northside Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Sutter Auburn Faith Hospital Coordinator of this site? Confirm its status | Auburn | United States | Unknown status |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Mary Bird Perkins Cancer Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Woman's Hospital Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| UHHS-Chagrin Highlands Medical Center Coordinator of this site? Confirm its status | Beachwood | United States | Unknown status |
| Henry Ford Cancer Institute-Downriver Coordinator of this site? Confirm its status | Brownstown | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Fairview Ridges Hospital Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Miami Valley Hospital South Coordinator of this site? Confirm its status | Centerville | United States | Unknown status |
| Geauga Hospital Coordinator of this site? Confirm its status | Chardon | United States | Unknown status |
| West Virginia University Charleston Division Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| John H Stroger Jr Hospital of Cook County Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Cancer Center/Fairview Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Riverside Methodist Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| The Mark H Zangmeister Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Unknown status |
| Women's Cancer Care-Covington Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| Parkland Memorial Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Danbury Hospital Coordinator of this site? Confirm its status | Danbury | United States | Unknown status |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Henry Ford Medical Center-Fairlane Coordinator of this site? Confirm its status | Dearborn | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| Fairview Southdale Hospital Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Unknown status |
| Parkview Regional Medical Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| CTCA at Western Regional Medical Center Coordinator of this site? Confirm its status | Goodyear | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| South Carolina Cancer Specialists PC Coordinator of this site? Confirm its status | Hilton Head Island | United States | Unknown status |
| Ascension Saint Vincent Indianapolis Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| West Michigan Cancer Center Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Northwestern Medicine Lake Forest Hospital Coordinator of this site? Confirm its status | Lake Forest | United States | Unknown status |
| Women's Cancer Center of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Hospital Pavilion and Medical Campus Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Norton Suburban Hospital and Medical Campus Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Fairview Clinics and Surgery Center Maple Grove Coordinator of this site? Confirm its status | Maple Grove | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Unknown status |
| Hillcrest Hospital Cancer Center Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Abbott-Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Marshfield Medical Center - Minocqua Coordinator of this site? Confirm its status | Minocqua | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| UC Comprehensive Cancer Center at Silver Cross Coordinator of this site? Confirm its status | New Lenox | United States | Unknown status |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Norwalk Hospital Coordinator of this site? Confirm its status | Norwalk | United States | Unknown status |
| Henry Ford Medical Center-Columbus Coordinator of this site? Confirm its status | Novi | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Nebraska Methodist Hospital Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Chicago Medicine-Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Unknown status |
| Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Cancer Institute (UPCI) Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Legacy Good Samaritan Hospital and Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Women and Infants Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Beebe Health Campus Coordinator of this site? Confirm its status | Rehoboth Beach | United States | Unknown status |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Unknown status |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center Coordinator of this site? Confirm its status | Rio Rancho | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Sutter Roseville Medical Center Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| Sutter Medical Center Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Park Nicollet Clinic - Saint Louis Park Coordinator of this site? Confirm its status | Saint Louis Park | United States | Unknown status |
| United Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| California Pacific Medical Center-Pacific Campus Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Sarasota Memorial Hospital Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Summit Cancer Care-Candler Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Robert Wood Johnson University Hospital Somerset Coordinator of this site? Confirm its status | Somerville | United States | Unknown status |
| CoxHealth South Hospital Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Mercy Hospital Springfield Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Unknown status |
| Barnes-Jewish Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Munson Medical Center Coordinator of this site? Confirm its status | Traverse City | United States | Unknown status |
| Legacy Meridian Park Hospital Coordinator of this site? Confirm its status | Tualatin | United States | Unknown status |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
| The Carle Foundation Hospital Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
| Legacy Salmon Creek Hospital Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| Marshfield Clinic-Wausau Center Coordinator of this site? Confirm its status | Wausau | United States | Unknown status |
| Henry Ford West Bloomfield Hospital Coordinator of this site? Confirm its status | West Bloomfield | United States | Unknown status |
| UHHS-Westlake Medical Center Coordinator of this site? Confirm its status | Westlake | United States | Unknown status |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Asplundh Cancer Pavilion Coordinator of this site? Confirm its status | Willow Grove | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Minnesota Oncology Hematology PA-Woodbury Coordinator of this site? Confirm its status | Woodbury | United States | Unknown status |
| UMass Memorial Medical Center - Memorial Division Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
| Midwestern Regional Medical Center Coordinator of this site? Confirm its status | Zion | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.