Prostate Cancer Clinical Trial
Official title:
A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases
RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with
progressive prostate cancer and bone metastases.
OBJECTIVES:
Primary
- Determine the time to progression in patients with progressive androgen-independent
prostate cancer with bone metastases treated with tandutinib.
Secondary
- Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using
the PSA Working Group Criteria, in patients treated with this regimen .
- Evaluate modulation of bone pain and bone markers in patients treated with this
regimen.
- Determine the objective tumor response by RECIST (Response Evaluation Criteria In Solid
Tumors) criteria in patients treated with this regimen.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
OUTLINE: Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every
28 days in the absence of disease progression or unacceptable toxicity.
Bone pain is assessed at baseline, on day 1 of course 3, and at disease progression.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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