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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: | NCT00041093 |
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 patients who have persistent or recurrent cervical cancer.
Condition | Intervention | Phase |
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Cervical Cancer |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix |
Study Start Date: | June 2002 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within at least 6-7 months.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 unidimensionally measurable target lesion
One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent squamous cell carcinoma of the cervix required
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Agustin Garcia, MD | Cedars-Sinai Medical Center |
Study ID Numbers: | CDR0000069442, GOG-0127S |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00041093 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cervical cancer cervical squamous cell carcinoma |
Docetaxel Epidermoid Carcinoma Neoplasms, Squamous Cell Squamous Cell Carcinoma |
Carcinoma, Squamous Cell Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Docetaxel Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Pharmacologic Actions Neoplasms, Glandular and Epithelial Carcinoma |