Ovarian Carcinoma Clinical Trial
Official title:
Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
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 gemcitabine will be effective in reducing or eliminating the tumor(s) in
patients with ovarian cancer.
Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast
and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung
cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer.
Both drugs have been shown to decrease the size of ovarian cancer tumors.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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