Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00006002
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00006002
Study Brief:
Protocol Section:
NCT00006002