Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Inclusion Criteria

• •Subjects must have signed an approved informed consent.
• •Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage II or III, with optimal (≤ or equal to 1 cm residual disease) residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage. Pathology must be verified at Memorial Sloan-Kettering Cancer Center.
• •Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
• •Subjects must have a Karnofsky Performance Status (KPS) of ≥ or equal to 70%.
• •Subjects must be entered no more than 12 weeks postoperatively.
• •Bone marrow function:
• •Absolute neutrophil count (ANC) ≥ than or equal to 1,500/µl (equivalent to Common Toxicity Criteria (CTC) Grade 1)
• •Platelets ≥ than or equal to 100,000/µl (CTC Grade 0-1)
• •Renal function: Creatinine ≤ than or equal to 1.5 mg/dl
• •Hepatic function: Bilirubin ≤ than or equal to 1.5 x ULN (CTC Grade 1) AST ≤ than or equal to 2.5 x ULN (CTC Grade 1)
• •Neurologic function:Neuropathy (sensory) ≤ than CTC Grade 1
• •Urine Protein Creatinine: Urine protein creatinine (UPC) ratio must be \< than 1.0 gm. If UPC ratio \> than or equal to 1, collection of 24-hour urine measurement of urine protein is recommended as part of the patient's medical management off-study. \*
• •UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formulas:
• •\[urine protein\]/\[urine creatinine\] - if both protein and creatinine are reported in mg/dL
• •\[(urine protein) x0.088\]/\[urine creatinine\] - if urine creatinine is reported in mmol/L
• •The UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine). Send sample to lab with request for urine protein and creatinine levels \[separate requests\]. The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR \< 1.0 to allow participation in the study.
• •Blood coagulation parameters:
• •PT such that international normalized ratio (INR) is \< than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT \< 1.2 times the upper limit of normal.
• •Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least 6 months after receiving the final treatment of bevacizumab.
• •Patients must have an Intraperitoneal (IP) port in place. If a patient does not have an IP port, she must be willing to undergo surgical placement of one.