Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803
NCT ID: NCT00897351
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
37 participants
OBSERVATIONAL
2008-07-10
2009-02-10
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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mutation analysis
polymorphism analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of prostate cancer
* Recurrent disease
* Received lapatinib ditosylate on clinical trial ECOG-E5803
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Jill Kolesar, PharmD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Other Identifiers
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ECOG-E5803T1
Identifier Type: -
Identifier Source: secondary_id
CDR0000600985
Identifier Type: -
Identifier Source: org_study_id
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