(pga) for platinum-resistant/refractory, paclitaxel-pretreated recurrent ovarian and peritoneal carcinoma

Conditions: Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Summary: to evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

this study will evaluate progression-free survival (pfs)for the regimen of gemcitabine and bevacizumab with or without a platinum agent on platinum-resistant/refractory ovarian and peritoneal carcinoma

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer 2. disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories: 1. primary platinum-refractory: previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy 2. primary platinum-resistant: previously untreated patients who have achieved at least a partial response to platinum-based chemotherapy but experience a relapse within a period of 6 months of its conclusion 3. secondary platinum-refractory: previously treated patients have a relapse 6 months after the conclusion of chemotherapy, but fail to achieve at least a partial response 4. secondary platinum-resistant: previously treated patients have a relapse 6 months after the conclusion of chemotherapy, achieve at least a partial response with platinum-based therapy as 2nd-line therapy, but experience relapse within 6 months 3. eastern cooperative oncology group (ecog) performance status score ≤ 2 and a life expectancy \>3 months. 4. absolute neutrophil count \> 1500 mm\^3, platelet count ≥ 100×10\^9 l, hemoglobin ≥ 8.5 g/dl 5. serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dl, ast/alt ≤ 5 times the upper limit of normal range 6. no remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the principal investigator 7. at least three (3) weeks from prior chemotherapy exclusion criteria: 1. inadequate renal function with a calculated creatinine clearance less than 51 ml/min 2. uncontrolled cardiac disease, congestive heart failure, angina, or hypertension 3. myocardial infarction or unstable angina within 2 months of treatment 4. known human immunodeficiency virus (hiv) infection or chronic active hepatitis b or c (patients are not required to be tested for the presence of such viruses prior to therapy on this protocol) 5. thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months 6. bleeding diathesis or significant coagulopathy 7. pulmonary hemorrhage/bleeding event ≥ ctcae grade 2 within 4 weeks of first dose of study drug 8. any other hemorrhage/bleeding event ≥ ctcae grade 3 within 4 weeks of first dose of study drug 9. history of fistula, gi perforation, or intrabdominal abscess 10. serious non-healing wound, ulcer, or bone fracture 11. clinical signs or symptoms of gi obstruction and/or requirement for parenteral hydration or nutrition 12. known cns disease except for treated brain metastasis 13. known platinum drug allergy 14. prior treatment with platinum + gemcitabine + avastin, gemcitabine + avastin or gemcitabine alone 15. prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy 16. major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug 17. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements 18. concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements