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, IND #7921) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

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