Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00002721|
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : May 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Procedure: drug resistance inhibition treatment||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER|
|Study Start Date :||March 1995|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
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|
- Respond to therapy [ Time Frame: six months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|