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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00176527 |
RATIONALE: Isotretinoin may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Interferon alfa-2b may interfere with the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Biological: recombinant interferon alfa-2b Drug: docetaxel Drug: estramustine phosphate sodium Drug: isotretinoin Genetic: polyacrylamide gel electrophoresis Genetic: protein expression analysis Other: immunohistochemistry staining method |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | January 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral isotretinoin once daily on days 1-4, recombinant interferon alfa-2b subcutaneously once daily on days 1-4, oral estramustine phosphate sodium three times daily on days 1-5, and docetaxel IV over 1 hour on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2, 3, or 4 and analyzed for bcl-2 protein by IHC and electrophoresis.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed hormone-refractory metastatic prostate cancer
PATIENT CHARACTERISTICS:
AST, ALT, and alkaline phosphatase (AP) must meet 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
United States, New Jersey | |
Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000540176, CINJ-3850 |
Study First Received: | September 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00176527 History of Changes |
Health Authority: | United States: Institutional Review Board |
recurrent prostate cancer stage IV prostate cancer |
Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Antineoplastic Agents, Hormonal Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Interferons Estramustine Urogenital Neoplasms Genital Diseases, Male Angiogenesis Inhibitors |
Antiviral Agents Hormones Recurrence Docetaxel Isotretinoin Tretinoin Antineoplastic Agents, Alkylating Interferon Alfa-2a Alkylating Agents Prostatic Neoplasms Interferon Alfa-2b |
Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Prostatic Diseases Genital Neoplasms, Male Immunologic Factors Antineoplastic Agents Estramustine Physiological Effects of Drugs Urogenital Neoplasms Docetaxel Neoplasms by Site Therapeutic Uses Isotretinoin Angiogenesis Modulating Agents |
Growth Inhibitors Dermatologic Agents Alkylating Agents Interferon-alpha Antineoplastic Agents, Hormonal Growth Substances Interferons Genital Diseases, Male Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Antineoplastic Agents, Alkylating Interferon Alfa-2a Interferon Alfa-2b |