NCT00002721

Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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: Phase I trial to study the effectiveness of doxorubicin plus estramustine in treating patients with metastatic recurrent prostate cancer that does not respond to hormone therapy.

Detailed description

OBJECTIVES: I. Estimate the maximum tolerated dose of weekly intravenous doxorubicin (DOX) that can be given in combination with oral estramustine (EM) in patients with metastatic prostate cancer refractory to treatment with hormonal agents. II. Assess the frequency of expression of the multidrug resistance phenotype in biopsy specimens from these patients. III. Assess the response to DOX/EM in these patients. OUTLINE: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Estramustine, EM, NSC-89199. PROJECTED ACCRUAL: Three to 18 patients will be entered.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	doxorubicin hydrochloride
DRUG	estramustine phosphate sodium
PROCEDURE	drug resistance inhibition treatment

Timeline

• Start date: 1995-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2004-05-26
• Last updated: 2014-05-21

Locations

1 site across 1 country: United States