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(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

Platinum-Gemcitabine-Avastin (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

NCT01936974•Western Regional Medical Center

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+1 more criteria

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
+8 more criteria

Locations (1)

Western Regional Medical Center

Goodyear, Arizona, United States

Key Dates

Start Date

September 1, 2013

Primary Completion Date

August 1, 2015

Completion Date

August 1, 2015

Last Updated

February 20, 2018

Enrollment

ACTUAL participants

Conditions

Ovarian CarcinomaFallopian Tube CarcinomaPeritoneal Carcinoma

Interventions

Gemcitabine

DRUG

Bevacizumab

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Oxaliplatin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma

Inclusion Criteria

Exclusion Criteria

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