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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028769 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: bicalutamide Drug: estramustine phosphate sodium Drug: etoposide Drug: flutamide Drug: goserelin Drug: leuprolide acetate Drug: nilutamide Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastic Adenocarinoma of the Prostate |
Study Start Date: | December 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate
Clinical stage D2 disease as evidenced by one of the following:
No prior or concurrent (treated or untreated) brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | David C. Smith, MD | University of Michigan Cancer Center |
Study ID Numbers: | CDR0000069132, SWOG-S0032 |
Study First Received: | January 4, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00028769 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Genital Neoplasms, Male Prostatic Diseases Nilutamide Estramustine Goserelin Urogenital Neoplasms Flutamide Genital Diseases, Male |
Etoposide phosphate Recurrence Paclitaxel Leuprolide Bicalutamide Adenocarcinoma Prostatic Neoplasms Etoposide |
Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Fertility Agents, Female Therapeutic Uses Tubulin Modulators Fertility Agents Antineoplastic Agents, Alkylating Alkylating Agents Antineoplastic Agents, Phytogenic |