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

• ClinicalTrials.gov Identifier: NCT02713386
• Recruitment Status: Active, not recruiting
• First Posted: March 18, 2016
• Last Update Posted: June 2, 2022
• Sponsor: NRG Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): NRG Oncology

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube High Grade Serous Adenocarcinoma; FIGO Stage III Ovarian Cancer; FIGO Stage IIIA Ovarian Cancer; FIGO Stage IIIA1 Ovarian Cancer; FIGO Stage IIIA2 Ovarian Cancer; FIGO Stage IIIB Ovarian Cancer; FIGO Stage IIIC Ovarian Cancer; FIGO Stage IVA Ovarian Cancer; FIGO Stage IVB Ovarian Cancer; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian High Grade Serous Adenocarcinoma; Primary Peritoneal Endometrioid Adenocarcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Stage III Fallopian Tube Cancer AJCC v7; Stage III Primary Peritoneal Cancer AJCC v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7	Drug: Carboplatin; Drug: Paclitaxel; Drug: Ruxolitinib Phosphate; Procedure: Therapeutic Conventional Surgery	Phase 1; Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine whether treatment with ruxolitinib phosphate (ruxolitinib) in combination with conventional neoadjuvant and post-surgical chemotherapy is safe and tolerable in the primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. (Phase I) II. Demonstrate whether treatment with ruxolitinib in combination with conventional neoadjuvant and post-surgical chemotherapy results in a prolonged progression-free survival when compared to chemotherapy alone, in primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. (Phase II)

SECONDARY OBJECTIVES:

I. Determine frequency of patients who do not receive surgery within 6 weeks of completing cycle 3 therapy for reasons other than non-response, disease progression, or medical contraindications. (Phase I) II. Determine if continuation of ruxolitinib as maintenance therapy in participants who complete 6 cycles of standard chemotherapy in combination with ruxolitinib and have not experienced unacceptable toxicity or disease progression is safe and tolerable. (Phase I) III. Determine the impact of ruxolitinib in combination with chemotherapy on progression-free survival as a function of proposed exploratory biomarkers - ALDH+ CD133+ (possibly also CD24+ CK19+) co-staining by AQUA immunofluorescence (IF); ratio of tumor expression of CD8:FOXP3 by immunohistochemistry (IHC); and tumor CD3, CD4, TAI-1, HLA class I and II, CD68 expression by IHC in archived tumor tissue, BRCA status, and serum C-reactive protein (CRP) and IL-6 levels in pre-treatment serum. (Phase II) IV. Investigate the prognostic significance of exploratory laboratory parameters in terms of both progression-free survival and overall survival in women receiving conventional chemotherapy alone. (Phase II) V. Determine whether treatment with ruxolitinib in combination with conventional chemotherapy is associated with total gross resection rate at time of interval cytoreductive surgery. (Phase II) VI. Determine whether treatment with ruxolitinib in combination with conventional chemotherapy is associated with complete pathologic response defined at interval cytoreductive surgery. (Phase II) VII. Demonstrate whether treatment with ruxolitinib in combination with conventional chemotherapy results in an improvement in overall survival in primary management of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of ruxolitinib phosphate, followed by a phase II study.

PHASE I PORTION OF STUDY IS COMPLETE (04/06/2018)

PHASE I (CYCLES 1-3): Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-21, paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 6 weeks after completion of cycle 3, patients undergo tumor reductive surgery (TRS).

PHASE I (CYCLES 4-6): Within 6 weeks of TRS, patients receive ruxolitinib phosphate PO BID on days 1-21, paclitaxel IV over 1 hour on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. If TRS is not performed due to non-response or medical contraindications and criteria for discontinuation of protocol therapy have not been met, patients should resume ruxolitinib phosphate, paclitaxel, and carboplatin within 6 weeks of completing cycle 3 of therapy.

MAINTENANCE THERAPY: Within 3 weeks after completion of cycle 6, patients receive ruxolitinib phosphate PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 treatment arms.

ARM I (CYCLES 1-3): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 6 weeks after completion of cycle 3, patients undergo TRS.

ARM I (CYCLES 4-6): Within 4 weeks of surgery (or within 6 weeks of completion of cycle 3 in patients who do not undergo TRS), patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM II (CYCLES 1-3): Patients receive ruxolitinib phosphate PO BID on days 1-21 and paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Within 6 weeks after completion of cycle 3, patients undergo TRS.

ARM II (CYCLES 4-6): Within 4 weeks of surgery (or within 6 weeks of completion of cycle 3 in patients who do not undergo TRS), patients receive ruxolitinib phosphate PO BID on days 1-21 and paclitaxel and carboplatin as in arm I. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients in phase I are followed up until resolution of adverse events, and patients in phase II are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 147 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: November 14, 2016
• Actual Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm I (paclitaxel and carboplatin); See Detailed Description.	Drug: Carboplatin; Given IV; Other Names: Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carboplatinum; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; Drug: Paclitaxel; Given IV; Other Names: Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat; Procedure: Therapeutic Conventional Surgery; Undergo TRS
Experimental: Arm II (ruxolitinib, paclitaxel, and carboplatin); See Detailed Description.	Drug: Carboplatin; Given IV; Other Names: Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carboplatinum; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; Drug: Paclitaxel; Given IV; Other Names: Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat; Drug: Ruxolitinib Phosphate; Given PO; Other Names: INCB-18424 Phosphate; Jakafi; Procedure: Therapeutic Conventional Surgery; Undergo TRS

Outcome Measures

Primary Outcome Measures :

1. Incidence of hematologic (heme) dose-limiting toxicity (Phase I) [ Time Frame: 42 days (2 cycles) ]
   Will be assessed according to Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).
2. Progression-free survival (PFS) (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
   Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A log-rank test utilizing the categorized values of the exploratory laboratory parameters or a Cox proportional hazards (PH) model to estimate of the hazard ratio for progression or death in PFS. If feasible, the PH model will examine the effect of continuous measures.

Secondary Outcome Measures :

1. Incidence of adverse events (Phase I) [ Time Frame: Up to 5 years ]
   Will be assessed according to CTEP CTCAE version 4.03 (CTCAE version 5.0 will be used starting 04/01/2018).
2. Frequency of patients who could not receive surgery within the defined timeframe for reasons other than non-response, disease progression, or medical contraindications (Phase I) [ Time Frame: Up to 6 weeks ]
   Frequencies will be given by the dose-level administered.
3. Number of patients who discontinue ruxolitinib in the first 3 months of maintenance therapy due to toxicity (Phase I) [ Time Frame: Up to 3 months in the maintenance phase ]
4. Progression-free survival (PFS) (Phase II) [ Time Frame: From study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
   Will be assessed according to RECIST 1.1. Subset analyses within categorized, important exploratory laboratory parameters will examine the treatment effect on PFS. The effect of treatment on PFS will be examined within each of these subsets using a log-rank test or a Cox PH model. Interest will center on whether the hazard of PFS changes from one group to another. The impact of the biomarkers on PFS will be assessed using log-rank tests or Cox PH models.
5. Proportion of patients who have total gross resection (Phase II) [ Time Frame: At the time of surgery ]
   Will be defined as no visible or palpable tumor remaining after completion of surgery. Differences in the proportion who have total gross resection by treatment arm will be examined with Fisher's Exact Test. The results of this analysis will be presented in terms of the odds ratio (maximum-likelihood estimations and confidence intervals). Multivariate logistic modeling will be conducted if feasible.
6. Complete pathological response (Phase II) [ Time Frame: Up to 5 years ]
   Will be defined as no evidence of disease on radiographic imaging at the time of radiographic tumor measurement. Differences in the proportion who have complete pathological response by treatment arm will be examined with Fisher's Exact Test. Multivariate logistic modeling will be conducted if feasible.
7. Overall survival (OS) (Phase II) [ Time Frame: From randomization until death or date last seen, assessed up to 5 years ]
   The effect of treatment on OS will be conducted with the log-rank statistic and characterized with a Cox PH model. The impact of the biomarkers on OS will be assessed using log-rank tests or Cox PH models.

Other Outcome Measures:

1. Change in cancer stem cells (CSC) observed in tissue [ Time Frame: Baseline up to 63 days (3 cycles) ]
   Landmark analyses will be conducted to see if changes in CSC are associated with PFS. The predictive value of CSC will be formally examined with a Cox model using an interaction term with treatment. Subset analyses will be conducted as well in the event that a formal analysis fails to reject the null hypothesis.
2. Change in serum C-reactive protein (CRP) [ Time Frame: Baseline up to 63 days (3 cycles) ]
   The impact of baseline values on PFS and OS can be assessed for prognostic and predictive significance with log-rank statistics and Cox models. The impact of changes in CRP values on PFS and OS can be examined with landmark analyses or as time dependent covariates.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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 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 with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma
• 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 who are not candidates for major abdominal surgery due to known medical comorbidities
• Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol
• Patients who are unwilling to be transfused with blood components
• 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
• Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

• 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
• 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)

Contacts and Locations

Locations

United States, Arizona

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States, 85338

United States, California

Sutter Auburn Faith Hospital

Auburn, California, United States, 95602

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Sutter Roseville Medical Center

Roseville, California, United States, 95661

Sutter Medical Center Sacramento

Sacramento, California, United States, 95816

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States, 94115

United States, Connecticut

Danbury Hospital

Danbury, Connecticut, United States, 06810

Norwalk Hospital

Norwalk, Connecticut, United States, 06856

United States, Delaware

Helen F Graham Cancer Center

Newark, Delaware, United States, 19713

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States, 19718

Beebe Health Campus

Rehoboth Beach, Delaware, United States, 19971

United States, Florida

Sarasota Memorial Hospital

Sarasota, Florida, United States, 34239

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30342

Augusta University Medical Center

Augusta, Georgia, United States, 30912

Memorial Health University Medical Center

Savannah, Georgia, United States, 31404

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States, 31405

Summit Cancer Care-Candler

Savannah, Georgia, United States, 31405

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States, 60612

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Carle on Vermilion

Danville, Illinois, United States, 61832

Carle Physician Group-Effingham

Effingham, Illinois, United States, 62401

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States, 60045

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States, 61938

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States, 60451

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States, 60462

Carle Cancer Center

Urbana, Illinois, United States, 61801

The Carle Foundation Hospital

Urbana, Illinois, United States, 61801

Midwestern Regional Medical Center

Zion, Illinois, United States, 60099

United States, Indiana

Parkview Regional Medical Center

Fort Wayne, Indiana, United States, 46845

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States, 46260

United States, Iowa

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States, 52242

United States, Kentucky

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States, 40202

Norton Suburban Hospital and Medical Campus

Louisville, Kentucky, United States, 40207

United States, Louisiana

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809

Woman's Hospital

Baton Rouge, Louisiana, United States, 70817

Women's Cancer Care-Covington

Covington, Louisiana, United States, 70433

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States, 70121

United States, Maryland

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States, 21287

United States, Massachusetts

UMass Memorial Medical Center - Memorial Division

Worcester, Massachusetts, United States, 01605

United States, Michigan

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States, 48183

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States, 48126

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States, 49503

West Michigan Cancer Center

Kalamazoo, Michigan, United States, 49007

Henry Ford Medical Center-Columbus

Novi, Michigan, United States, 48377

Munson Medical Center

Traverse City, Michigan, United States, 49684

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States, 48322

United States, Minnesota

Fairview Ridges Hospital

Burnsville, Minnesota, United States, 55337

Mercy Hospital

Coon Rapids, Minnesota, United States, 55433

Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States, 55369

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States, 55416

Regions Hospital

Saint Paul, Minnesota, United States, 55101

United Hospital

Saint Paul, Minnesota, United States, 55102

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States, 55125

United States, Missouri

Barnes-Jewish Hospital

Saint Louis, Missouri, United States, 63110

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

CoxHealth South Hospital

Springfield, Missouri, United States, 65807

United States, Nebraska

Nebraska Methodist Hospital

Omaha, Nebraska, United States, 68114

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, Nevada

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States, 89106

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States, 08876

United States, New Mexico

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87102

Southwest Gynecologic Oncology Associates Inc

Albuquerque, New Mexico, United States, 87106

Presbyterian Rust Medical Center/Jorgensen Cancer Center

Rio Rancho, New Mexico, United States, 87124

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States, 44122

Miami Valley Hospital South

Centerville, Ohio, United States, 45459

Geauga Hospital

Chardon, Ohio, United States, 44024

Case Western Reserve University

Cleveland, Ohio, United States, 44106

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States, 44111

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Riverside Methodist Hospital

Columbus, Ohio, United States, 43214

The Mark H Zangmeister Center

Columbus, Ohio, United States, 43219

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States, 44124

UHHS-Westlake Medical Center

Westlake, Ohio, United States, 44145

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

United States, Oregon

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States, 97210

Legacy Meridian Park Hospital

Tualatin, Oregon, United States, 97062

United States, Pennsylvania

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States, 19090

United States, Rhode Island

Women and Infants Hospital

Providence, Rhode Island, United States, 02905

United States, South Carolina

South Carolina Cancer Specialists PC

Hilton Head Island, South Carolina, United States, 29926-3827

United States, Tennessee

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

United States, Texas

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

United States, Virginia

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

United States, Washington

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98109

University of Washington Medical Center - Montlake

Seattle, Washington, United States, 98195

Legacy Salmon Creek Hospital

Vancouver, Washington, United States, 98686

United States, West Virginia

West Virginia University Charleston Division

Charleston, West Virginia, United States, 25304

United States, Wisconsin

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States, 54701

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States, 54449

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States, 54548

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States, 54868

Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, United States, 54482

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, United States, 54401

Marshfield Medical Center - Weston

Weston, Wisconsin, United States, 54476

Sponsors and Collaborators

NRG Oncology

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Charles N Landen; NRG Oncology

More Information

• Responsible Party: NRG Oncology
• ClinicalTrials.gov Identifier: NCT02713386
• Other Study ID Numbers: NRG-GY007; NCI-2016-00203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); NRG-GY007; NRG-GY007 ( Other Identifier: NRG Oncology ); NRG-GY007 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract )
• First Posted: March 18, 2016
• Last Update Posted: June 2, 2022
• Last Verified: June 2022

Additional relevant MeSH terms:

Adenocarcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Adenocarcinoma, Clear Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases