|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology 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 |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Thalidomide Goserelin Leuprolide acetate Leuprolide |
| 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 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | William Dahut, MD | NCI - Center for Cancer Research-Medical Oncology |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Gulley JL, Figg WD, Steinberg SM, Carter J, Sartor O, Higano CS, Petrylak DP, Chatta G, Hussain MH, Dahut WL. A prospective analysis of the time to normalization of serum androgens following 6 months of androgen deprivation therapy in patients on a randomized phase III clinical trial using limited hormonal therapy. J Urol. 2005 May;173(5):1567-71. Erratum in: J Urol. 2005 Aug;174(2):796. Sartor, Oliver [added]; Higano, Celestia S [added]; Petrylak, Daniel P [added] Chatta, Gerkamal [added].
  |
|
Gulley JL, Figg WD, Carter J, et al.: A prospective analysis of the time to normalization of serum testosterone (T) following 6 months of androgen deprivation therapy in patients on a randomized phase III clinical trial utilizing intermittent hormonal therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1592, 2003.
  |
| Study ID Numbers: | CDR0000067700, NCI-00-C-0080, NCI-T99-0053 |
| First Received: | July 11, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00020085 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|