Status:
COMPLETED
Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Aventis Pharmaceuticals
Eli Lilly and Company
Conditions:
Ovarian Carcinoma
Peritoneal Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study is for patients with advanced ovarian cancer that has reappeared after treatment with conventional therapy. The purpose of this study is to determine if the combination of docetaxel and gem...
Detailed Description
Primary Objective: 1\. To determine the response rate, time to progression and survival (secondary) of the combination of docetaxel and gemcitabine administered on a weekly basis to patients with pla...
Eligibility Criteria
Inclusion
- Histologically proven diagnosis of epithelial ovarian ca
- Must have platinum-resistant disease. (Defined as progression during the most recent platinum-based chemotx or relapse \< 6 months after the most recent platinum-based chemotx regimen.)
- Measurable or evaluable disease. (Patients whose dz is manifested only as an elevated CA-125 \[greater than or equal to 100\] are eligible. If an elevated CA-125 is the only manifestation of dz, it must be confirmed on 2 separate times, at least 2 weeks apart. Patients with positive cytology only are not eligible.)
- Greater than or equal to 18 years of age
- GOG performance status less than or equal to 2
- AGC/ANC greater than or equal to 1.5; platelets greater than or equal to 100,000; hemoglobin (Hgb) greater than or equal to 8.0.
- Creatinine less than or equal to 2.0
- Total bilirubin less than or equal to upper limit of normal (uln)
- SGOT and/or SGPT less than or equal to 2.5 x uln if alkaline phosphatase less than or equal to uln, or alkaline phosphatase less than or equal to 4 x uln if transaminases are less than or equal to uln. (If both SGOT/SGPT \>1.5 x uln and alkaline phosphatase \> 2.5 x uln, patient is not eligible.)
- Fully recovered from acute toxicities secondary to prior treatment (tx)
- Signed informed consent
Exclusion
- Prior treatment with gemcitabine or docetaxel
- Underlying medical, psychiatric, or social conditions that would preclude patient from receiving treatment
- Peripheral neuropathy greater than or equal to Grade 2
- No prior tx with cisplatin or carboplatin
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00183794
Start Date
November 1 2002
End Date
May 1 2010
Last Update
May 22 2014
Active Locations (1)
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1
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033