Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
RATIONALE: Lapatinib 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 lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.
|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 Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer|
- Proportion of patients with early hormone refractory prostate cancer experiencing decrease in measurable disease after treatment with lapatinib (GW572016). [ Time Frame: Every 12 weeks until disease progression ] [ Designated as safety issue: No ]Radiographic response will be measured using RECIST criteria for patients with measurable disease every 12 weeks. Subjects will be evaluated for CR (complete response), PR (partial response), SD (stable disease) or PD (progressive disease)
- Number of patients experiencing adverse events [ Time Frame: every 4 weeks of treatment ] [ Designated as safety issue: Yes ]Adverse events will be assessed (graded) using CTCAE critera
- Time to PSA progression [ Time Frame: every 4 weeks of treatment ] [ Designated as safety issue: No ]Efficacy monitoring will be assessed by serum PSA for those subjects without radiographic, measurable disease. Decrease in PSA value from baseline by > 50 % for 2 successive evaluations at least 4 weeks apart will be considered PSA repsonse.
- Predictive molecular markers in response to treatment with lapatinib (GW572016) [ Time Frame: every 4 weeks of treatment ] [ Designated as safety issue: No ]To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Drug: lapatinib ditosylate
- Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA after treatment with lapatinib ditosylate.
- Determine the safety of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
- Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Rex Cancer Center at Rex Hospital|
|Raleigh, North Carolina, United States, 27607|
|Principal Investigator:||Young Whang, MD, PhD||UNC Lineberger Comprehensive Cancer Center|