Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00095667
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Nov 30, 2004
Status verified
May 2013
Primary completion
Nov 30, 2007

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (lapatinib ditosylate)
    Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Primary Outcome Measure

PSA response rate defined as at least a 50% fall in PSA from baseline confirmed by a second PSA 4 weeks later [ Time Frame: Up to 3 years ]

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