Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
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
platinum-resistant ovarian cancer
Secondary Objective:
1. To determine the toxicity of this combination regimen in patients with
platinum-resistant ovarian cancer
2. To evaluate the toxicity and safety profile of a short course (one dose) of
premedication with steroids to patients receiving weekly gemcitabine and docetaxel
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and docetaxel IV
over 60 minutes on day 8. Treatment repeats every 21 days until PD, unacceptable toxicity,
or patient's withdrawal.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor Response Type: CR, PR, SD or PD
Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.
6 months after enrollment of last participant
No
Agustin Garcia, MD
Principal Investigator
University of Southern California
United States: Institutional Review Board
5GYN-02-2
NCT00183794
November 2002
May 2010
Name | Location |
---|---|
Norris Comprehensive Cancer Center | Los Angeles, California 90033 |