A Phase I Study Of SU5416 With Androgen Ablation And Radiation In Patients With Intermediate and Advanced Stage Prostate Cancer
OBJECTIVES: I. Determine the safety of SU5416 in combination with standard androgen ablation
and radiotherapy in patients with intermediate or advanced-stage prostate cancer.
OUTLINE: This is a multicenter, dose-escalation study of SU5416. Patients receive oral
bicalutamide once daily or oral flutamide three times daily for at least 1 month followed by
leuprolide or goserelin subcutaneously once monthly for four months. Beginning after the
fourth administration of leuprolide or goserelin, patients undergo radiotherapy 5 days a
week for 7-8 weeks. Beginning one month before radiotherapy and continuing until 1 month
after radiotherapy, patients receive SU5416 IV over 60 minutes on days 1 and 4. Treatment
repeats weekly in the absence of disease progression or unacceptable toxicity. Cohorts of
3-12 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which at least 3 of 12 patients
experience dose-limiting toxicity. Patients are followed every 4-6 weeks for 4 months and
then every 8-12 weeks for 8 months.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Side effects of SU5416 in combination with standard hormone treatment and radiation in men with prostate cancer
24 weeks
Yes
Walter M. Stadler, MD, FACP
Study Chair
University of Chicago
United States: Federal Government
11193A
NCT00026377
November 2001
April 2003
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
LaGrange Memorial Hospital | LaGrange, Illinois 60525 |
Radiation Oncology | Chicago, Illinois 60612 |