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OpenTrials
Completed

NCT Number: NCT00002721

Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin hydrochloride

Drug

estramustine phosphate sodium

Drug

drug resistance inhibition treatment

Procedure

Primary outcomes

  1. Respond to therapy

    Time frame: six months

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2013
Study completion
2013
First posted
May 26, 2004
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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