Clinical Trials Directory

Trials / Completed

CompletedNCT00095667

Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
41 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGlapatinib ditosylateGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2004-11-01
Primary completion
2007-11-01
First posted
2004-11-08
Last updated
2013-05-08

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00095667. Inclusion in this directory is not an endorsement.