Docetaxel in Treating Patients With Advanced Cancer of the Cervix

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Unidad Oncologica Del Comahue

Neuquén, 8300, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

Sponsors and collaborators

Lead sponsor

Grupo Oncologico Cooperativo del Sur

Other

Registry information

Official study title

Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Important dates

Study start: 1997
Study completion: 2004
First posted: Apr 23, 2004
Registry last updated: Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed