A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin (NSC #214240) and Intravenous Paclitaxel (NSC # 673089) and Intravenous Paclitaxel, Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab (NSC #704865) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

Date de début de l'étude : 1 juin 2004

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