Docetaxel in Treating Patients With Advanced Cancer of the Cervix

This study has been completed.

First Received: November 1, 1999 Last Updated: July 23, 2008 History of Changes

Sponsored by:	Grupo Oncologico Cooperativo del Sur
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003445

Purpose

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.

Condition	Intervention	Phase
Cervical Cancer	Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

December 1997

Detailed 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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003445

Locations

Argentina
Unidad Oncologica Del Comahue
Neuquen, Argentina, 8300

Sponsors and Collaborators

Grupo Oncologico Cooperativo del Sur

Investigators

Study Chair:

Carlos Teodoro Vallejo, MD

Grupo Oncologico Cooperativo del Sur

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066473, GOCS-04-CC-97, NCI-V98-1456
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003445 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma

Study placed in the following topic categories:

Docetaxel
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Epidermoid Carcinoma
Genital Neoplasms, Female

Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Antineoplastic Agents
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Pharmacologic Actions
Uterine Cervical Neoplasms
Genital Diseases, Female

Docetaxel
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009