Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803

Evaluation of Polymorphisms, Mutations, and Protein Expression by Automated Quantitative Immunohistochemistry (AQUA) in the LapatinibTargets and Metabolic Pathway in Samples From E5803

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897351

Enrollment

Registered

2009-05-12

Start date

2008-07-10

Completion date

2009-02-10

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer

Brief 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.

Interventions

GENETICmutation analysis

GENETICpolymorphism analysis

GENETICprotein expression analysis

OTHERimmunohistochemistry staining method

OTHERlaboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 120 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Polymorphisms associated with toxicity	1 month
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	1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026