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.
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
Walter M. Stadler, MD, FACP
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|LaGrange Memorial Hospital||LaGrange, Illinois 60525|
|Radiation Oncology||Chicago, Illinois 60612|