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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002723 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: chemotherapy Drug: suramin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER |
| Estimated Enrollment: | 378 |
| Study Start Date: | January 1996 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease site (bone only vs soft tissue), CALGB/Zubrod performance status (0 or 1 vs 2), number of prior hormonal therapies (1 or 2 vs 3), and participating center. Patients are randomized to 1 of 3 treatment arms.
Quality of life is assessed.
Patients are followed every 4 weeks until disease progression and then periodically for new primary cancer(s) and survival.
PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate with progressive metastatic or progressive regional nodal disease
Measurable disease preferred but not required
No more than 3 prior hormonal interventions for progressive disease
One prior hormonal intervention is defined by any of the following:
Two prior hormonal interventions are defined by the following:
Antiandrogen withdrawal not considered a separate hormonal intervention
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Veterans Affairs Medical Center - Lakeside Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018-1095 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Wisconsin | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Veterans Affairs Medical Center - Madison | |
| Madison, Wisconsin, United States, 53705 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| South Africa | |
| Pretoria Academic Hospitals | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
| Study Chair: | Daniel P. Petrylak, MD | Herbert Irving Comprehensive Cancer Center |
| Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
More Information
| Study ID Numbers: | CDR0000064583, CALGB-9480, E-C9480, SWOG-9452, INT-0159 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002723 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
|
Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Suramin Urogenital Neoplasms Anthelmintics |
Genital Diseases, Male Pharmacologic Actions Neoplasms Antiparasitic Agents Neoplasms by Site Therapeutic Uses Prostatic Neoplasms Antinematodal Agents |