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Docetaxel in Treating Patients With Advanced Cancer of the Cervix

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003445
First Posted: April 23, 2004
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
November 1, 1999
April 23, 2004
June 26, 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

Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
 
NCT00003445
GOCS-04-CC-97
CDR0000066473 ( Registry Identifier: PDQ (Physician Data Query) )
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