(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Conditions
Ovarian Carcinoma - Fallopian Tube Carcinoma - Peritoneal Carcinoma
Conditions: official terms
Carcinoma - Fallopian Tube Neoplasms - Ovarian Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Gemcitabine Type: Drug
Name: Bevacizumab Type: Drug
Name: Carboplatin Type: Drug
Name: Cisplatin Type: Drug
Name: Oxaliplatin Type: Drug
Overall Status
Recruiting
Summary
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
Location
Western Regional Medical Center
Goodyear, Arizona, United States
Status: Recruiting
Start Date
September 2013
Completion Date
September 2016
Sponsors
Western Regional Medical Center
Source
Western Regional Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page