A Phase I Trial of Intravenous Paclitaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Docetaxel, Intraperitoneal Carboplatin and Intraperitoneal Paclitaxel or Intravenous Paclitaxel, Intraperitoneal Carboplatin, Intraperitoneal Paclitaxel and CTEP-Supplied Agent Bevacizumab (NSC 704865, IND 7921) in Patients With Previously Untreated Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Date de début de l'étude : 1 mai 2004

Inclusion Criteria: * Histologically confirmed fallopian tube, ovarian epithelial, or primary peritoneal carcinoma * Stage II-IV disease * The following epithelial cell types are allowed: * Carcinosarcoma * Serous adenocarcinoma * Endometrioid adenocarcinoma * Mucinous adenocarcinoma * Undifferentiated carcinoma * Clear cell adenocarcinoma * Mixed epithelial carcinoma * Transitional cell carcinoma * Malignant Brenner's tumor * Adenocarcinoma not otherwise specified * Must have undergone prior surgery for ovarian or peritoneal carcinoma within the past 12 weeks * Optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery * Must have a procedure for determining diagnosis of ovarian/peritoneal carcinoma with appropriate tissue for histologic evaluation * Synchronous primary endometrial cancer or prior endometrial cancer allowed provided the following criteria are met: * Stage ≤ IB * Less than 3 mm invasion without vascular or lymphatic invasion * No poorly differentiated subtypes (e.g., grade 3, clear cell, or papillary serous) * No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas) * No CNS disease (e.g., seizures not controlled with standard medical therapy) or metastasis * GOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) (applies to part C only) * PTT \< 1.2 times the upper limit of normal (applies to part C only) * SGOT ≤ 2.5 times normal * Alkaline phosphatase ≤ 2.5 times normal * Bilirubin ≤ 1.5 times normal * Creatinine ≤ 1.5 times normal * No active bleeding * Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided disease has remained stable for the past 6 months * No unstable angina or myocardial infarction within the past 6 months * No neuropathy (sensory and motor) \> CTCAE grade 1 * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy * No septicemia, severe infection, or acute hepatitis * No other invasive malignancy within the past 5 years except non-melanoma skin cancer or localized breast cancer * No circumstance that would preclude study participation * No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E) * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies (applies to part C only) * No clinically significant proteinuria * Must have urine protein-creatinine ratio (UPCR) \< 1 * No serious, non-healing wound, ulcer, or bone fracture (applies to part C only) * At least 3-6 months since prior abdominal fistula or gastrointestinal perforation and fully recovered (part C only) * No history of intra-abdominal abscess within the past 28 days (applies to part C only) * No active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels (applies to part C only) * No history or evidence (upon physical examination) of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or brain metastases (applies to part C only) * No history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study (applies to part C only) * No significant traumatic injury within 28 days (applies to part C only) * No clinically significant cardiovascular disease, including any of the following (applies to part C only): * Uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg * Myocardial infarction or unstable angina \< 6 months prior to registration * New York Heart Association (NYHA) Grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication * CTCAE Grade 2 or greater peripheral vascular disease (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) * History of CVA within the past six months * No clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition (applies to part C only) * No prior therapy with any anti-VEGF drug, including bevacizumab (applies to part C only) * No prior chemotherapy * Prior adjuvant chemotherapy for localized breast cancer allowed provided the therapy was completed at least 3 years before registration to study and the patient remains free of recurrent or metastatic disease * No prior radiotherapy * No prior cancer therapy that would contraindicate study treatment * No anticipation of invasive procedures, including any of the following (applies to part C only): * Major surgical procedure or open biopsy within 28 days prior to the first date of bevacizumab therapy (cycle 2) * Major surgical procedure anticipated during the course of the study * Core biopsy within 7 days prior to the first date of bevacizumab therapy