Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
recurrent prostate cancer
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: mutation analysis Type: Genetic
Name: polymorphism analysis Type: Genetic
Name: protein expression analysis Type: Genetic
Name: immunohistochemistry staining method Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Not yet recruiting
Summary
RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.
Detailed Description
OBJECTIVES:

- To determine the association between polymorphisms in drug metabolizing enzymes and lapatinib ditosylate-associated toxicity in patients with hormone-sensitive recurrent prostate cancer receiving lapatinib ditosylate on clinical trial ECOG-E5803.

- To determine the association between mutations in EGFR, HER-2 and Kras; protein expression of HER2, EGFR, MAPK and AKT; polymorphism controlling androgen synthesis; and progression-free survival.

OUTLINE: Tissue and blood samples collected from patients enrolled on clinical trial ECOG-E5803 are analyzed for correlative studies. Samples are assessed for HER2, EGFR, MAPK, and Akt; EGFR mutations and polymorphisms in CYP3A4; Ras mutations; recently identified mutations in HER2-neu and Kras; and additional polymorphisms in the lapatinib ditosylate metabolic pathway by automated quantitative IHC. Predictors of efficacy and toxicity are analyzed, including markers in the EGFR pathway as predictors of progression-free survival.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Male
Criteria: DISEASE CHARACTERISTICS:

- Diagnosis of prostate cancer

- Recurrent disease

- Received lapatinib ditosylate on clinical trial ECOG-E5803

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
Location
Start Date
August 2008
Sponsors
Eastern Cooperative Oncology Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page