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A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

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