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CompletedNCT00897351Updated May 17, 2017

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

An observational study in Prostate Cancer, sponsored by ECOG-ACRIN Cancer Research Group. Completed. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by ECOG-ACRIN Cancer Research Group · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
37
Ages
18 Years to 120 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • recurrent prostate cancer
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In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 37 is below the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 121 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Samples submitted for research from patients enrolled on E5803

Eligibility 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
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
37 participants (actual)

Interventions

  • Geneticmutation analysis
  • Geneticpolymorphism analysis
  • Geneticprotein expression analysis
  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Polymorphisms associated with toxicity

    Time frame: 1 month

  2. 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

    Time frame: 1 month

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00897351
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jul 10, 2008
Primary completion
Feb 10, 2009
Completion
Feb 10, 2009
Last update
May 17, 2017

Study contacts

Jill Kolesar, PharmD
study chair · University of Wisconsin, Madison
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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