Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
- Registration Number
- NCT00002723
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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. 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.
- Detailed Description
OBJECTIVES:
I. Compare the response in patients with advanced hormone-refractory adenocarcinoma of the prostate treated with low- vs intermediate- vs high-dose suramin.
II. Compare the toxic effects of these regimens in these patients. III. Compare the overall and failure-free survival of patients treated with these regimens.
IV. Compare the duration of complete and partial responses in patients treated with these regimens.
V. Determine the population pharmacokinetics of these regimens and correlate these parameters with the toxicity of these regimens and response rate in these patients.
VI. Compare the quality of life of patients treated with these regimens. VII. Determine the relationship of absolute and relative decrease in PSA and rate of PSA decrease with the likelihood and duration of response in patients treated with these regimens.
VIII. Determine whether a change in fibroblast growth factor levels in patients treated with suramin can be associated with the pharmacokinetics of suramin or the likelihood of clinical response in these patients.
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.
Arm I: Patients receive low-dose suramin IV over 1 hour on days 1, 2, 8, 9, 29, 30, 36, 37, 57, 58, 64, and 65 in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive intermediate-dose suramin as in arm I.
Arm III: Patients receive high-dose suramin as in arm I. Patients with new progression after partial or complete response may receive additional courses, at the discretion of the study chairperson, beginning at least 12 weeks after completion of the first course and continuing in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed.
Patients are followed every 4 weeks until disease progression and then periodically for new primary cancer(s) and survival.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 390
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose suramin Suramin Low dose suramin Intermediate dose suramin Suramin Intermediate dose suramin High dose suramin Suramin High dose suramin
- Primary Outcome Measures
Name Time Method Response Week 12 and every 12 weeks thereafter Radiographic evaluation
- Secondary Outcome Measures
Name Time Method Toxicity pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up Survival post treatment until patient expires Quality of Life pre-study, 2 weeks post treatment, and every 12 weeks in follow up
Trial Locations
- Locations (27)
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa