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| Sponsored by: |
Beth Israel Deaconess Medical Center |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004081 |
Purpose
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 | Intervention | Phase |
|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: docetaxel |
Phase II |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Drug Information available for: | Docetaxel |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 1999 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Platinum resistance as defined by one of the following:
PATIENT CHARACTERISTICS:
Age:
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No other malignancies within the past 3 years, except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | |||||
| Boston, Massachusetts, United States, 02215 | |||||
| Beth Israel Deaconess Medical Center |
| Study Chair: | Stephen A. Cannistra, MD | Beth Israel Deaconess Medical Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067292, BIH-99-1286, NCI-V99-1565 |
| First Received: | December 10, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004081 |
| Health Authority: | United States: Federal Government |
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