A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER
18 Years
N/A
Male
Prostate Cancer
Trial Information
A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER
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.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Anthony Y. Smith, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of New Mexico Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000064574
NCT ID:
NCT00002721
Start Date:
March 1995
Completion Date:
Related Keywords:
- Prostate Cancer
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
