Brief Title
(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Official Title
Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
Brief 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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival
Condition
Ovarian Carcinoma
Intervention
Gemcitabine
Study Arms / Comparison Groups
Platinum, Gemcitabine and Bevacizumab
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
7
Start Date
September 2013
Completion Date
August 2015
Primary Completion Date
August 2015
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jordan Waypa, FNP, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01936974
Organization ID
13-27
Responsible Party
Sponsor
Study Sponsor
Western Regional Medical Center
Study Sponsor
Jordan Waypa, FNP, Study Director, Western Regional Medical Center
Verification Date
January 2018