(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Ovarian Carcinoma - Fallopian Tube Carcinoma - Peritoneal Carcinoma
Conditions: official terms
Carcinoma - Fallopian Tube Neoplasms - Ovarian Neoplasms
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Name: Gemcitabine Type: Drug
Name: Bevacizumab Type: Drug
Name: Carboplatin Type: Drug
Name: Cisplatin Type: Drug
Name: Oxaliplatin Type: Drug
Overall Status
To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma
Detailed Description
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Western Regional Medical Center
Goodyear, Arizona, United States
Status: Recruiting
Start Date
September 2013
Completion Date
September 2016
Western Regional Medical Center
Western Regional Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page