NCT00003445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
Last Updated

June 26, 2013

Status Verified

September 1, 2001

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Cervical Cancer

Keywords

stage III cervical cancerstage IIB cervical cancerstage IVA cervical cancercervical squamous cell carcinoma

Interventions

docetaxelDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unidad Oncologica Del Comahue

Neuquén, 8300, Argentina

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Carlos Teodoro Vallejo, MD

    Grupo Oncologico Cooperativo del Sur

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 23, 2004

Study Start

December 1, 1997

Study Completion

April 1, 2004

Last Updated

June 26, 2013

Record last verified: 2001-09

Locations

AR(1)