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Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer



Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

For Condition: recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): University of New Mexico ,
Synopsis: 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.
Details: 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. PROTOCOL OUTLINE: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Estramustine, EM, NSC-89199. PROJECTED ACCRUAL: Three to 18 patients will be entered.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Biopsy proven metastatic prostate cancer; Biopsy requirement waived at principal investigator's discretion if new disease site technically inaccessible and PSA elevated - Recurrent disease following orchiectomy, estrogen, or gonadotropin-releasing hormone agonist therapy - If previously irradiated: Progressive disease outside prior radiotherapy field required - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior doxorubicin or estramustine - Endocrine therapy: See Disease Characteristics; At least 30 days since flutamide Estrogen or gonadotropin-releasing hormone agonists discontinued prior to treatment - Radiotherapy: At least 6 weeks since radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 1.5 mg/dL; ALT/AST less than 3 times greater than normal - Renal: Not specified - Cardiovascular: Left ventricular ejection fraction at least 45%; No NYHA class III/IV status; No unstable angina - Other: No Crohn's disease, ulcerative colitis, or other inflammatory bowel syndrome
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnthonySmith,  Study Chair,  University of New Mexico

University of New Mexico Cancer Research & Treatment Center
Albuquerque,  New Mexico,  87131
United States
 


Additional Information:
Study ID Numbers:  CDR0000064574;  UNM-2394C,NCI-V96-0816
Study Start Date: March 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002721

Other Recurrent Prostate Cancer Studies:
1. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

2. Brachytherapy in Treating Patients With Recurrent Prostate Cancer

3. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

4. R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence

5. Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer

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Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
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