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Doxorubicin |
Adriamycin; Rubex |
Clinical Trial: Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| recurrent prostate cancer | Drug: doxorubicin Drug: estramustine | Phase I |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Doxorubicin/Estramustine in Hormone-Refractory Metastatic Prostate Cancer
Study start: 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.
PROTOCOL 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 above
Criteria
PROTOCOL ENTRY 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
--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
--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
Location Information
New Mexico
University of New Mexico Cancer Research & Treatment Center, Albuquerque, New Mexico, 87131, United States
Anthony Y. Smith, Study Chair, University of New Mexico
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002721
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Adriamycin (Drug Digest)
- Doxorubicin (Drug Digest)
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