Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma
About this trial
This is an interventional treatment trial for Brenner Tumor
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer Stage II-IV disease The following histologic epithelial cell types are eligible: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner's tumor Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks) Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true: Stage IB disease or less Less than 3 mm invasion without vascular or lymphatic invasion No poorly differentiated subtypes, including the following: Papillary serous Clear cell Other FIGO grade 3 lesions No epithelial tumors of low malignant potential (borderline tumors) No CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases by history or evidence upon physical examination within the past 6 months Performance status - GOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 INR ≤ 1.5 PTT < 1.2 times upper limit of normal (ULN) No active bleeding or pathologic conditions carrying high risk of bleeding (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels) AST ≤ 3 times upper limit of normal (ULN) Alkaline phosphatase ≤ 3 times ULN Bilirubin ≤ 1.5 times ULN No acute hepatitis Creatinine ≤ 2.0 mg/dL Urine protein-creatinine ratio < 1.0 OR protein 1.0 g by 24 hour urine collection Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for ≥ 6 months before study entry No clinically significant cardiovascular disease, including any of the following: Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg Myocardial infarction or unstable angina within the past 6 months New York Heart Association class II-IV congestive heart failure Serious cardiac arrhythmia requiring medication Peripheral vascular disease ≥ CTCAE grade 2 (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within the past 6 months Not pregnant or nursing Fertile patients must use effective contraception during and for ≥ 6 months after completion of bevacizumab therapy No neuropathy (sensory and motor) > grade 1 No active infection requiring antibiotics No circumstances that would preclude study participation No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies No history of allergic reaction to polysorbate 80 (e.g., etoposide, vitamin E) No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer No serious, non-healing wound, ulcer, or bone fracture No significant traumatic injury within 28 days prior to bevacizumab therapy No prior history of abdominal fistula or gastrointestinal perforation within the past 3-6 months Granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection allowed but require weekly wound examinations No clinical symptoms or signs of gastrointestinal obstruction requiring parenteral hydration and/or nutrition At least 28 days since intra-abdominal abscess and recovered At least 3 years since prior adjuvant chemotherapy for localized breast cancer Patients must remain free of recurrent or metastatic disease At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin Patient must remain free of recurrent or metastatic disease No prior radiotherapy to any portion of the abdominal cavity or pelvis No concurrent amifostine or other protective agents No concurrent major surgical procedure or open biopsy or within 28 days prior to bevacizumab therapy No core biopsy within 7 days prior to bevacizumab therapy No prior therapy for this malignancy No prior cancer treatment that contraindicates study therapy No prior anti-VEGF drug, including bevacizumab
Sites / Locations
- University of California Medical Center At Irvine-Orange Campus
- University of Chicago
- University of Iowa Hospitals and Clinics
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Cooper Hospital University Medical Center
- Wake Forest University Health Sciences
- Riverside Methodist Hospital
- Cancer Care Associates-Midtown
- Tulsa Cancer Institute
- Gynecologic Oncology Group
- Fox Chase Cancer Center
- Women and Infants Hospital
- M D Anderson Cancer Center
- Pacific Gynecology Specialists
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Seattle Cancer Care Alliance
- University of Washington Medical Center
- Kawasaki Medical School
- Saitama Medical University International Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (adjuvant, paclitaxel, carboplatin, bevacizumab)
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.