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