Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident By a Rising PSA
- Determine the percentage of patients with hormone-sensitive recurrent prostate cancer
treated with GW572016 (lapatinib) who experience > 50% decline in serum
prostate-specific antigen (PSA).
- Determine the duration of PSA decline in patients treated with this drug.
- Determine the change in slope of a linear graph depicting PSA values in these patients
before, during, and after treatment with this drug.
- Determine the safety and tolerability of this drug in these patients.
- Determine the time to progression and 2-year progression-free survival of patients
treated with this drug.
- Correlate epidermal growth factor receptor expression/signaling with change in PSA in
patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral GW572016 (lapatinib) once daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level
PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period. CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response. PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later.
Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
Glenn Liu, MD
University of Wisconsin, Madison
United States: Federal Government