Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients
For every five patients randomized, two will receive treatment number 1 (irofulven +
prednisone), two patients will receive treatment number 2 (irofulven + capecitabine
(Xeloda®) + prednisone), and one patient will receive treatment number 3 (mitoxantrone +
prednisone). This is not a blinded study, so both the patient and doctor will know which
treatment has been assigned.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression: RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Between randomization and study discontinuation or disease progression, whichever occurs later.
No
United States: Food and Drug Administration
IROF-018
NCT00124566
June 2004
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Great Falls, Montana 59405 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Little Rock, Arkansas 72205-7199 | |
Denver, Colorado | |
Milwaukee, Wisconsin | |
Charleston, South Carolina |