Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
Borderline Ovarian Mucinous Tumor, Ovarian Mucinous Cystadenocarcinoma, Recurrent Fallopian Tube Carcinoma
About this trial
This is an interventional treatment trial for Borderline Ovarian Mucinous Tumor
Eligibility Criteria
Inclusion Criteria:
- Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or no measurable disease
- All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
- Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve)
- Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization
- Patients must have a negative colonoscopy within 1 year of enrolling in the study
- Absolute neutrophil count (ANC) >= 1,500/mcl
- White blood cell (WBC) count >= 3,000/mcl
- Platelets >= 100,000/mcl
- Hemoglobin (Hgb) >= 10 g/dl (can be post transfusion)
- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance > 50 cc/min
- Bilirubin =< 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) =< to 2.5 x ULN
- Alkaline phosphatase =< to 2.5 x ULN
- Neuropathy (sensory and motor) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Urine dipstick for proteinuria < 2+; if urine dipstick is >= 2+, 24 hour urine must demonstrate =< 1 g protein in 24 hours OR patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL
- Prothrombin time (PT) =< 1.5 x ULN
- Activated prothrombin time (APTT) =< 1.5 x ULN
- Patients of childbearing potential must agree to practice an effective form of birth control during study treatment and for six months after completion of treatment
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients with Gynecologic Oncology Group (GOG) performance grade of 0, 1 or 2
- Patients with life expectancy > 3 months
Exclusion Criteria:
- Patients with known colon cancer or history of colon cancer
- Patients with primary peritoneal carcinoma
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does include breast cancer) or colorectal cancer prior to enrollment
- Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures
- Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed > 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing
- Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy)
- Patients with a history of abdominal fistula or perforation within the past 12 months
- Patients with a current, serious, non-healing wound, ulcer, or bone fracture; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
- Patients with known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies
- Patients with mixed epithelial ovarian cancer histology
- Patients with tumors of low malignant potential
- History or evidence of upon physical examination of central nervous system (CNS) disease, including history of primary brain tumor or any history of brain metastases, or seizures not controlled with standard medical therapy
- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm Hg; patients with a history of hypertension are permitted
- Myocardial infarction or unstable angina within 12 months of the first date of bevacizumab therapy
- New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < 50% will be excluded from the study
- Grade 1, category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise
- History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab therapy
- History of pulmonary embolism or deep vein thrombosis in the past 6 months
- Previous history of malabsorption or other conditions preventing oral treatment
- Patients who are pregnant or nursing
- Patients with acute hepatitis or active infection that requires parenteral antibiotics
- Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels
- Patients taking warfarin
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Saint Joseph's Hospital and Medical Center
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Valley Medical Oncology Consultants-Fremont
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- El Camino Hospital
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Olive View-University of California Los Angeles Medical Center
- The Medical Center of Aurora
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Western States Cancer Research NCORP
- Swedish Medical Center
- Poudre Valley Hospital
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Hartford Hospital
- The Hospital of Central Connecticut
- Stamford Hospital/Bennett Cancer Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- University of Florida Health Science Center - Gainesville
- AdventHealth Orlando
- Augusta University Medical Center
- John B Amos Cancer Center
- Northeast Georgia Medical Center-Gainesville
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Queen's Medical Center
- University of Hawaii Cancer Center
- Kapiolani Medical Center for Women and Children
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- University of Chicago Comprehensive Cancer Center
- Heartland Cancer Research NCORP
- Eureka Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Illinois CancerCare-Havana
- Mason District Hospital
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Swedish American Hospital
- Illinois CancerCare-Spring Valley
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Ascension Saint Vincent Indianapolis Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- Cancer Care Partners LLC
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Saint Elizabeth Healthcare Edgewood
- University of Kentucky/Markey Cancer Center
- Pikeville Medical Center
- Cancer Center of Acadiana
- Ochsner Medical Center Jefferson
- Greater Baltimore Medical Center
- Walter Reed National Military Medical Center
- Christiana Care - Union Hospital
- Baystate Medical Center
- Green Bay Oncology - Escanaba
- Green Bay Oncology - Iron Mountain
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Lakeland Hospital Niles
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- University of Mississippi Medical Center
- Southeast Cancer Center
- Capital Region Southwest Campus
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Nebraska Methodist Hospital
- Women's Cancer Center of Nevada
- Cooper Hospital University Medical Center
- Virtua Memorial
- Virtua Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- UNC Lineberger Comprehensive Cancer Center
- Duke University Medical Center
- Wayne Memorial Hospital
- AdventHealth Hendersonville
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Summa Health System - Akron Campus
- Mary Rutan Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grady Memorial Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Marietta Memorial Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Knox Community Hospital
- Licking Memorial Hospital
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Jefferson Abington Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- University of Pittsburgh Cancer Institute (UPCI)
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- Women and Infants Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Saint Francis Hospital
- Spartanburg Medical Center
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- University of Tennessee - Knoxville
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Memorial Hermann Texas Medical Center
- Danville Regional Medical Center
- Hematology Oncology Associates of Fredericksburg Inc
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic-Sheboygan
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Aurora West Allis Medical Center
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm I (carboplatin and paclitaxel)
Arm II (oxaliplatin and capecitabine)
Arm III (carboplatin, paclitaxel, bevacizumab)
Arm IV (oxaliplatin, capecitabine, bevacizumab)
Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.