Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

Recurrent Prostate Cancer Clinical Trial

Official title: A Phase 2 Study of GW572016 in Hormone Naive Recurrent or Metastatic Hormone Sensitive Prostate Cancer

Status Completed

Clinical Trial Summary

Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the antitumor activity of GW572016 in hormone naïve, recurrent and/or metastatic hormone sensitive prostate cancer using PSA response rate.

SECONDARY OBJECTIVES:

I. To estimate objective tumor response in patients with measurable disease. II. To determine the duration of PSA response, rate and duration of stable disease, progression-free, median and overall survival rates of GW572016 in recurrent and/or metastatic prostate cancer.

III. To document the safety and tolerability of GW572016 in these patient populations.

TERTIARY OBJECTIVES:

I. To investigate if differences in baseline levels of EGFR and/or erbB2 expression, and receptor phosphorylation status in tumor specimens predict outcome to therapy.

II. To investigate if the inhibitory effects of GW572016 on EGFR and/or erbB2 pathway activation in tumor specimens correlates with clinical outcome.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 11.7 months. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

• NCT number: NCT00095667
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: November 2004