Fallopian Tube Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma
Conditions
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
Interventions
DRUGGemcitabine
Patient to receive gemzar
DRUGBevacizumab
Patient to receive avastin
DRUGCarboplatin
Patient to receive carboplatin
DRUGCisplatin
Patient to receive cisplatin
DRUGOxaliplatin
Patient to receive Oxaliplatin
Sponsors
Western Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | One Year | Evaluate progression-free survival between the two regimens. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platinum, Gemcitabine and Bevacizumab Platinum:
1. Carboplatin\* on day 1
\*If a patient is allergic to carboplatin, then give
2. Cisplatin\*\* on day 1
\*\*If a patient is allergic to cisplatin and carboplatin, then give
3. Oxaliplatin on day 1
Gemcitabine on day 1 only
Bevacizumab on day 1
Gemcitabine
Bevacizumab
Carboplatin
Cisplatin
Oxaliplatin | 0 |
| Gemcitabine and Bevacizumab Gemcitabine on days 1 and 8
Bevacizumab on day 1
Gemcitabine
Bevacizumab | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 5 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Progression-free Survival
Evaluate progression-free survival between the two regimens.
Time frame: One Year
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.