Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00002721

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-03-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate cancer patients

Prostate cancer patients that have not responded to hormon therapy

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

estramustine phosphate sodium

Intervention Type: DRUG

drug resistance inhibition treatment

Intervention Type: PROCEDURE

Interventions

doxorubicin hydrochloride

Intervention Type: DRUG

estramustine phosphate sodium

Intervention Type: DRUG

drug resistance inhibition treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Y. Smith, MD

Role: STUDY_CHAIR

University of New Mexico Cancer Center

Locations

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

CDR0000064574

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V96-0816

Identifier Type: -

Identifier Source: secondary_id

UNM-2394C

Identifier Type: -

Identifier Source: org_study_id