Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00004081|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 13, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cavity Cancer||Drug: docetaxel||Phase 2|
- Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer|
|Study Start Date :||July 1999|
|Primary Completion Date :||January 2002|
|Study Completion Date :||March 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004081
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Stephen A. Cannistra, MD||Beth Israel Deaconess Medical Center|