Docetaxel in Treating Patients With Advanced Cancer of the Cervix

NCT ID: NCT00003445

Last Updated: 2013-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Grupo Oncologico Cooperativo del Sur

OTHER

Sponsor Role lead

Principal Investigators

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Carlos Teodoro Vallejo, MD

Role: STUDY_CHAIR

Grupo Oncologico Cooperativo del Sur

Locations

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Unidad Oncologica Del Comahue

Neuquén, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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CDR0000066473

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V98-1456

Identifier Type: -

Identifier Source: secondary_id

GOCS-04-CC-97

Identifier Type: -

Identifier Source: org_study_id

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