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Docetaxel in Treating Patients With Advanced Cancer of the Cervix

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003445
First received: November 1, 1999
Last updated: June 25, 2013
Last verified: September 2001

November 1, 1999
June 25, 2013
December 1997
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Complete list of historical versions of study NCT00003445 on ClinicalTrials.gov Archive Site
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Docetaxel in Treating Patients With Advanced Cancer of the Cervix
Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

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 with advanced cancer of the cervix.

OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Interventional
Phase 2
Primary Purpose: Treatment
Cervical Cancer
Drug: docetaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2004
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DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified

Female
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No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00003445
GOCS-04-CC-97, CDR0000066473, NCI-V98-1456
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Grupo Oncologico Cooperativo del Sur
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Study Chair: Carlos Teodoro Vallejo, MD Grupo Oncologico Cooperativo del Sur
National Cancer Institute (NCI)
September 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP