Clinical trial NCT01936974: (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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Carcinoma
Fallopian Tube Carcinoma
Peritoneal Carcinoma
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Progression-free Survival
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center
state: Arizona
Study officials:
affiliation: Western Regional Medical Center
name: Jordan Waypa, FNP
role: STUDY_DIRECTOR
References: