Tandutinib in Treating Patients With Progressive Prostate Cancer and 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases|
- 8-week Freedom-From-Progression (FFP) [ Time Frame: 8 weeks; repeat assessments performed every 8 weeks after criteria for response first met. ] [ Designated as safety issue: No ]Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.
|Study Start Date:||October 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: Tandutinib (MLN518)
500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases. Tandutinib (MLN518) previously known as CT53518.
500 mg twice daily every day with doses taken approximately 12 hours apart, 28 day cycle.
Other Name: CT53518
- Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390468
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Paul Mathew, MD||UT MD Anderson Cancer Center|