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NCT01124669 Clinical Trial

Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Lung Cancer Clinical Trial

Official title:
BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01124669
Other study ID # CDR0000670998
Secondary ID ECOG-E2501T2
Status Completed
Phase N/A
First received May 14, 2010
Last updated May 16, 2017
Start date June 13, 2010
Est. completion date July 13, 2010

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Description:

OBJECTIVES:

- To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.

- To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.

OUTLINE: This is a multicenter study.

DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date July 13, 2010
Est. primary completion date July 13, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of refractory non-small cell lung cancer

- Received sorafenib tosylate on protocol ECOG-E2501

- Available blood specimens

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• mutation analysis

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR 1 mont
Primary Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response) 1 month
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