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Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT00276549 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-01-31

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with metastatic prostate cancer.

Conditions

Interventions

DRUG

docetaxel

docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

DRUG

gemcitabine hydrochloride

IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Robert Dreicer, MD, FACP · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00276549 on ClinicalTrials.gov