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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004081 |
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 |
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Ovarian Cancer Peritoneal Cavity Cancer |
Drug: docetaxel |
Phase II |
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.
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:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Study Chair: | Stephen A. Cannistra, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000067292, BIH-99-1286, NCI-V99-1565 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004081 History of Changes |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Recurrence |
Docetaxel Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions |
Adnexal Diseases Docetaxel Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |