Prostate Cancer Clinical Trial
Official title:
A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer
RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the
tumor. Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is
not yet known whether SU5416 or dexamethasone is more effective in treating progressive
prostate cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of
dexamethasone in treating patients who have progressive prostate cancer that has not
responded to hormone therapy.
OBJECTIVES:
- Compare the time to progression in patients with hormone refractory prostate cancer
treated with dexamethasone with or without SU5416.
- Determine the differences in PSA kinetics and PSA hazard score between these two
regimens in this patient population.
- Determine the objective response rate and time to development of new lesions in these
patients treated with SU5416.
- Determine the toxicity of SU5416 in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral dexamethasone once a day 6 days a week. Treatment
continues until disease progression, at which time patients cross over to arm II.
- Arm II: Patients receive oral dexamethasone as in arm I followed by SU5416 IV over 60
minutes twice weekly for 4 weeks. A smaller dose of dexamethasone is administered the
day after SU5416. Treatment continues for a minimum of 2 courses in the absence of
unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
16 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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