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NCT00003445 Clinical Trial

Docetaxel in Treating Patients With Advanced Cancer of the Cervix

Cervical Cancer Clinical Trial

Official title:
Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003445
Other study ID # GOCS-04-CC-97
Secondary ID CDR0000066473NCI
Status Completed
Phase Phase 2
First received November 1, 1999
Last updated June 25, 2013
Start date December 1997
Est. completion date April 2004

Study information
Verified date September 2001
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• docetaxel

Locations
Country Name City State
Argentina Unidad Oncologica Del Comahue Neuquen

Sponsors (1)
Lead Sponsor Collaborator
Grupo Oncologico Cooperativo del Sur

Country where clinical trial is conducted

Argentina, 

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