(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

Study Overview
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Brief Summary
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To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

Detailed Description
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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

Official Title
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Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

Conditions
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Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Bevacizumab
* Drug: Carboplatin
* Drug: Cisplatin
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age with histologically confirmed, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer Disease progression during or within 6 months of previous platinum-based chemotherapy including the following 4 categories: Primary platinum-refractory: Previously untreated patients who do not achieve at least a partial response to platinum-based chemotherapy 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 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 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 Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months. Absolute neutrophil count > 1500 mm^3, platelet count ≥ 100×10^9 L, hemoglobin ≥ 8.5 g/dL 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 No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator At least three (3) weeks from prior chemotherapy Exclusion Criteria: Inadequate renal function with a calculated creatinine clearance less than 51 mL/min Uncontrolled cardiac disease, congestive heart failure, angina, or hypertension Myocardial infarction or unstable angina within 2 months of treatment 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) Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks, pulmonary embolism within the past 6 months Bleeding diathesis or significant coagulopathy Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug History of fistula, GI perforation, or intrabdominal abscess Serious non-healing wound, ulcer, or bone fracture clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition Known CNS disease except for treated brain metastasis Known platinum drug allergy Prior treatment with Platinum + Gemcitabine + Avastin, Gemcitabine + Avastin or Gemcitabine alone Prior treatment with more than three (3) lines of chemotherapy including adjuvant chemotherapy Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platinum, Gemcitabine and Bevacizumab<br>Platinum: Carboplatin* on day 1 *If a patient is allergic to carboplatin, then give Cisplatin** on day 1 **If a patient is allergic to cisplatin and carboplatin, then give Oxaliplatin on day 1 Gemcitabine on day 1 only Bevacizumab on day 1 | Drug: Gemcitabine<br>* Patient to receive gemzar<br>* Other names: Gemzar;Drug: Bevacizumab<br>* Patient to receive avastin<br>* Other names: Avastin;Drug: Carboplatin<br>* Patient to receive carboplatin<br>* Other names: Paraplatin;Drug: Cisplatin<br>* Patient to receive cisplatin<br>* Other names: Platinol;Drug: Oxaliplatin<br>* Patient to receive Oxaliplatin<br>* Other names: Eloxatin;|
| Active Comparator: Gemcitabine and Bevacizumab<br>Gemcitabine on days 1 and 8 Bevacizumab on day 1 | Drug: Gemcitabine<br>* Patient to receive gemzar<br>* Other names: Gemzar;Drug: Bevacizumab<br>* Patient to receive avastin<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Evaluate progression-free survival between the two regimens. | One Year |