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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085332 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).
Condition | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
Study Start Date: | July 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma
Measurable disease
At least 1 target lesion
Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Agustin Garcia, MD | Premiere Oncology |
Study ID Numbers: | CDR0000368634, GOG-0129N |
Study First Received: | June 10, 2004 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00085332 |
Health Authority: | United States: Federal Government |
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Docetaxel Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms |
Urogenital Neoplasms Endometrial cancer Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |