Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
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.
Drug: doxorubicin hydrochloride
Drug: estramustine phosphate sodium
Procedure: drug resistance inhibition treatment
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER|
- Respond to therapy [ Time Frame: six months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 1995|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Prostate cancer patients
Prostate cancer patients that have not responded to hormon therapy
|Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Procedure: drug resistance inhibition treatment|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002721
|United States, New Mexico|
|University of New Mexico Cancer Research & Treatment Center|
|Albuquerque, New Mexico, United States, 87131|
|Study Chair:||Anthony Y. Smith, MD||University of New Mexico Cancer Center|