Prostate Cancer Clinical Trial
Official title:
Evaluation of Polymorphisms, Mutations, and Protein Expression by Automated Quantitative Immunohistochemistry (AQUA) in the LapatinibTargets and Metabolic Pathway in Samples From E5803
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.
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.
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