(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent 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

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