Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00103194
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.

Key Dates

Start date
Sep 30, 2005
Status verified
Jun 2014
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level [ Time Frame: 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ECOG-ACRIN Cancer Research GroupPhiladelphiaPennsylvania19103-

Find similar trials in Philadelphia, PA

By research site
ECOG-ACRIN Cancer Research Group· Philadelphia, PA

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