Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: doxorubicin hydrochloride; Drug: estramustine phosphate sodium; Procedure: drug resistance inhibition treatment

• Registration Number: NCT00002721
• Lead Sponsor: University of New Mexico

Brief 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.

Study Timeline

• Study Start: 1995-03
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-25
• Study First Posted: 2004-05-26
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate cancer patients	doxorubicin hydrochloride	Prostate cancer patients that have not responded to hormon therapy
Prostate cancer patients	estramustine phosphate sodium	Prostate cancer patients that have not responded to hormon therapy
Prostate cancer patients	drug resistance inhibition treatment	Prostate cancer patients that have not responded to hormon therapy

Primary Outcome Measures

Name	Time	Method
Respond to therapy	six months

Trial Locations

Locations (1)

University of New Mexico Cancer Research & Treatment Center; 🇺🇸 Albuquerque, New Mexico, United States