Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002721
• Other study ID #: UNM-2394C
• Secondary ID: CDR0000064574NCI
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: May 20, 2014
• Start date: March 1995
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• doxorubicin hydrochloride

• estramustine phosphate sodium

Procedure:
• drug resistance inhibition treatment

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respond to therapy		six months	Yes