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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

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.

Condition Intervention
Prostate Cancer
Genetic: mutation analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Evaluation of Polymorphisms, Mutations, and Protein Expression by Automated Quantitative Immunohistochemistry (AQUA) in the LapatinibTargets and Metabolic Pathway in Samples From E5803

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Polymorphisms associated with toxicity [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: August 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of prostate cancer

    • Recurrent disease
  • Received lapatinib ditosylate on clinical trial ECOG-E5803


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00897351

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Jill Kolesar, PharmD University of Wisconsin, Madison
  More Information

No publications provided Identifier: NCT00897351     History of Changes
Other Study ID Numbers: CDR0000600985  ECOG-E5803T1 
Study First Received: May 9, 2009
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 11, 2016