Docetaxel in Treating Patients With Advanced Cancer of the Cervix

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Argentina

Study Type

Interventional

Intervention

docetaxel

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring stage III cervical cancer, stage IIB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Unidad Oncologica Del Comahue

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003445

First Posted

November 1, 1999

Last Updated

June 25, 2013

Sponsor

Grupo Oncologico Cooperativo del Sur

1. Study Identification

Unique Protocol Identification Number

NCT00003445

Brief Title

Docetaxel in Treating Patients With Advanced Cancer of the Cervix

Official Title

Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2001

Overall Recruitment Status

Completed

Study Start Date

December 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Grupo Oncologico Cooperativo del Sur

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Teodoro Vallejo, MD

Organizational Affiliation

Grupo Oncologico Cooperativo del Sur

Official's Role

Study Chair

Facility Information:

Facility Name

Unidad Oncologica Del Comahue

City

Neuquen

ZIP/Postal Code

8300

Country

Argentina

Cervical Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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