Spots Global Cancer Trial Database for Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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