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Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer

NCT00003084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-07-30

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.

Conditions

Interventions

DRUG

Doxorubicin Hydrochloride

Doxorubicin IV on days 1, 15, and 29.

DRUG

Estramustine phosphate sodium

Arm I: Oral estramustine three times a day for 21 day cycle. Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle.

DRUG

Etoposide

Oral etoposide twice daily on days 1-14.

DRUG

Ketoconazole

Oral ketoconazole three times a day on days 1-7, 15-21, and 29-35.

DRUG

Paclitaxel

IV over 1 hour on day 2.

DRUG

Vinblastine

IV on days 8, 22, and 36.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Randall E. Millikan, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-12-31
Primary Completion
2002-11-30
Completion
2002-11-30

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 NCT00003084 on ClinicalTrials.gov