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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020085 |
Purpose
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Leuprolide and goserelin may fight prostate cancer by reducing the production of androgens. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. It is not yet known whether leuprolide or goserelin plus thalidomide is more effective than leuprolide or goserelin alone for prostate cancer.
PURPOSE: This randomized phase III trial is studying leuprolide or goserelin plus thalidomide to see how well they work compared to leuprolide or goserelin alone in treating patients with nonmetastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: goserelin Drug: leuprolide acetate Drug: thalidomide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Double Blind Randomized Crossover Phase III Study of Oral Thalidomide Versus Placebo in Patients With Stage D0 Androgen Dependent Prostate Cancer Following Limited Hormonal Ablation |
| Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, crossover, double-blind, placebo-controlled, multicenter study.
Patients with a rising prostate-specific antigen (PSA) are randomized to receive leuprolide or goserelin intramuscularly monthly for 6 months, followed by oral thalidomide or oral placebo daily. At the time of PSA progression, patients receive an additional 6 months of monthly leuprolide or goserelin therapy. After 6 months, patients originally treated with thalidomide are crossed over to the placebo arm or vice versa until PSA progression or development of metastatic disease is observed.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed nonmetastatic (stage D0 by Jewett classification system; stage IV by TNM classification system) adenocarcinoma of the prostate
Progressive disease defined as:
Eligible for late entry provided the following are true:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Louisiana | |
| Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Virginia | |
| Naval Medical Center, Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Study Chair: | William Dahut, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000067700, NCI-00-C-0080, NCI-T99-0053 |
| Study First Received: | July 11, 2001 |
| Last Updated: | April 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020085 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Anti-Infective Agents Immunologic Factors Thalidomide Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Reproductive Control Agents Anti-Bacterial Agents Neoplasms by Site Leuprolide Therapeutic Uses Angiogenesis Modulating Agents |
Growth Inhibitors Antineoplastic Agents, Hormonal Growth Substances Goserelin Genital Diseases, Male Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Fertility Agents, Female Fertility Agents Prostatic Neoplasms Leprostatic Agents |