A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Week 12 and then monthly
Eric J. Small, MD
University of California, San Francisco
United States: Food and Drug Administration
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|Veterans Affairs Medical Center - East Orange||East Orange, New Jersey 07018-1095|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|CCOP - Duluth||Duluth, Minnesota 55805|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|CCOP - Toledo Community Hospital Oncology Program||Toledo, Ohio 43623-3456|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|Veterans Affairs Medical Center - Madison||Madison, Wisconsin 53705|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)||Milwaukee, Wisconsin 53295|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|CCOP - Marshfield Medical Research and Education Foundation||Marshfield, Wisconsin 54449|
|Veterans Affairs Medical Center - Minneapolis||Minneapolis, Minnesota 55417|
|Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus||Nashville, Tennessee 37212|