(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Condition: Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma
MeSH terms: Carcinoma
Intervention: Gemcitabine; Bevacizumab; Carboplatin; Cisplatin; Oxaliplatin
Intervention description: Patient to receive gemzar; Patient to receive avastin; Patient to receive carboplatin; Patient to receive cisplatin; Patient to receive Oxaliplatin
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate progression-free survival with two chemotherapy regimens 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