Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity.

Interventions: intervention 1: lapatinib ditosylate
Intervention descriptions: intervention 1: 1500 mg, daily until disease progression

Protocol document: