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| Sponsored by: |
University of New Mexico |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002721 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Procedure: drug resistance inhibition treatment |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER |
| Estimated Enrollment: | 18 |
| Study Start Date: | March 1995 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New Mexico | |
| University of New Mexico Cancer Research & Treatment Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| Study Chair: | Anthony Y. Smith, MD | University of New Mexico |
More Information
| Study ID Numbers: | CDR0000064574, UNM-2394C, NCI-V96-0816 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002721 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Estramustine Urogenital Neoplasms Genital Diseases, Male Hormones |
Recurrence Doxorubicin Anti-Bacterial Agents Antineoplastic Agents, Alkylating Prostatic Neoplasms Alkylating Agents |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Estramustine Urogenital Neoplasms Genital Diseases, Male Antibiotics, Antineoplastic |
Doxorubicin Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Prostatic Neoplasms |
