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.
OBJECTIVES: Primary * Determine the proportion of patients with hormone-refractory prostate cancer who experience \> 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate. Secondary * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
1500 mg, daily until disease progression
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States
Number of Patients Experiencing Decline in Prostate-specific Antigen
Determine the number of patients with hormone-refractory prostate cancer who experience \> 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.
Time frame: 4 years
Time to Prostate-Specific Antigen (PSA) Progression
Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
Time frame: 4 years
Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016)
To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
Time frame: 4 years
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