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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: | Cancer and Leukemia Group B |
| 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: suramin Drug: Suramin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 390 |
| Study Start Date: | January 1996 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low dose suramin
Low dose suramin
|
Drug: suramin
3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.
Other Name: NSC #34936
|
|
Experimental: Intermediate dose suramin
Intermediate dose suramin
|
Drug: suramin
5.320 g/square meter total dose given in decreasing concentrations in 250 cc normal saline via IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65
Other Name: NSC #34936
|
|
Experimental: High dose suramin
High dose suramin
|
Drug: Suramin
7.661 g/square meter toal dose given in decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,5,58,64,and 65.
Other Name: NSC #34936
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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
Show 27 Study Locations| Study Chair: | Eric J. Small, MD | University of California, San Francisco |
| Study Chair: | Daniel P. Petrylak, MD | Herbert Irving Comprehensive Cancer Center |
| Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
More Information
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00002723 History of Changes |
| Other Study ID Numbers: | CDR0000064583, U10CA031946, CALGB-9480, E-C9480, SWOG-9452, INT-0159 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Suramin Antinematodal Agents |
Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Trypanocidal Agents Antiprotozoal Agents |