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

Who is this study for? Adult women with ovarian, fallopian tube, or peritoneal cancer
Status: Active_not_recruiting
Location: See all (112) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Arizona
CTCA at Western Regional Medical Center
Goodyear
California
Sutter Auburn Faith Hospital
Auburn
UC San Diego Moores Cancer Center
La Jolla
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
Sutter Roseville Medical Center
Roseville
Sutter Medical Center Sacramento
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
Connecticut
Danbury Hospital
Danbury
Norwalk Hospital
Norwalk
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Helen F Graham Cancer Center
Newark
Beebe Health Campus
Rehoboth Beach
Florida
Sarasota Memorial Hospital
Sarasota
Georgia
Northside Hospital
Atlanta
Augusta University Medical Center
Augusta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Memorial Health University Medical Center
Savannah
Summit Cancer Care-Candler
Savannah
Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
Carle at The Riverfront
Danville
Carle Physician Group-Effingham
Effingham
Northwestern Medicine Lake Forest Hospital
Lake Forest
Carle Physician Group-Mattoon/Charleston
Mattoon
UC Comprehensive Cancer Center at Silver Cross
New Lenox
University of Chicago Medicine-Orland Park
Orland Park
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Midwestern Regional Medical Center
Zion
Indiana
Parkview Regional Medical Center
Fort Wayne
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Kentucky
Norton Hospital Pavilion and Medical Campus
Louisville
Norton Suburban Hospital and Medical Campus
Louisville
Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge
Woman's Hospital
Baton Rouge
Women's Cancer Care-Covington
Covington
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
UMass Memorial Medical Center - Memorial Division
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Michigan
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Medical Center-Fairlane
Dearborn
Henry Ford Hospital
Detroit
Spectrum Health at Butterworth Campus
Grand Rapids
West Michigan Cancer Center
Kalamazoo
Henry Ford Medical Center-Columbus
Novi
Munson Medical Center
Traverse City
Henry Ford West Bloomfield Hospital
West Bloomfield
Minnesota
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Abbott-Northwestern Hospital
Minneapolis
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Missouri
Barnes-Jewish Hospital
Saint Louis
Washington University School of Medicine
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
North Carolina
Wake Forest University Health Sciences
Winston-salem
Nebraska
Nebraska Methodist Hospital
Omaha
University of Nebraska Medical Center
Omaha
New Jersey
Hackensack University Medical Center
Hackensack
Rutgers Cancer Institute of New Jersey
New Brunswick
Robert Wood Johnson University Hospital Somerset
Somerville
New Mexico
Southwest Gynecologic Oncology Associates Inc
Albuquerque
University of New Mexico Cancer Center
Albuquerque
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho
Nevada
Women's Cancer Center of Nevada
Las Vegas
New York
Roswell Park Cancer Institute
Buffalo
University of Rochester
Rochester
Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood
Miami Valley Hospital South
Centerville
Geauga Hospital
Chardon
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
MetroHealth Medical Center
Cleveland
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Hillcrest Hospital Cancer Center
Mayfield Heights
UHHS-Westlake Medical Center
Westlake
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Legacy Good Samaritan Hospital and Medical Center
Portland
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Pennsylvania Hospital
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Asplundh Cancer Pavilion
Willow Grove
Rhode Island
Women and Infants Hospital
Providence
South Carolina
South Carolina Cancer Specialists PC
Hilton Head Island
Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Virginia
University of Virginia Cancer Center
Charlottesville
Washington
FHCC South Lake Union
Seattle
Fred Hutchinson Cancer Research Center
Seattle
University of Washington Medical Center - Montlake
Seattle
Legacy Salmon Creek Hospital
Vancouver
Wisconsin
Marshfield Medical Center-EC Cancer Center
Eau Claire
University of Wisconsin Carbone Cancer Center
Madison
Marshfield Medical Center-Marshfield
Marshfield
Medical College of Wisconsin
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
Marshfield Medical Center-Rice Lake
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Marshfield Clinic-Wausau Center
Wausau
Marshfield Medical Center - Weston
Weston
West Virginia
West Virginia University Charleston Division
Charleston
Time Frame
Start Date: 2016-11-14
Completion Date: 2025-08-01
Participants
Target number of participants: 147
Treatments
Active_comparator: Arm I (paclitaxel and carboplatin)
See Detailed Description.
Experimental: Arm II (ruxolitinib, paclitaxel, and carboplatin)
See Detailed Description.
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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