Status: Closed
Activation Date: 2004JUN21
Closing Date: 2005DEC20
Phase: II
Description: Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer
Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease.
Objective: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression.
Participation: Limited to invited centres only.
Lay Description: The main purpose of this study is to find out what effects an experimental drug called BAY43-9006 has on patients with prostate cancer which has stopped responding to hormone therapy, and to find out the side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples (from a sample of the tumour that was removed at the time of the initial diagnosis) to find out what effects BAY43-9006 has on individual cancer cells. Patients who meet all of the eligibility criteria will be given a supply of BAY43-9006 pills to take one every day. Treatment will be repeated every 4 weeks.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I167 | 28 | 10 | 16 | 26 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I167 | 28 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I167 | 28 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |