Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy

NCT ID: NCT00694603

Last Updated: 2012-09-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.

Detailed Description

• Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.
• The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.

Conditions

Non-small Cell Lung Cancer

Keywords

cetuximab; tyrosine kinase inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab

400mg/m2 IV x 1 and then 250mg/m2 IV weekly

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

Given intravenously once per week.

Interventions

Cetuximab

Given intravenously once per week.

Intervention Type: DRUG

Other Intervention Names

Erbitux

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC
• Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway
• Measurable disease, as defined by RECIST criteria
• Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable
• Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
• ECOG Performance Status 0-2
• 18 years of age or older
• Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
• Bone marrow function, renal function, hepatic function as outlined in protocol

Exclusion Criteria

• Women who are pregnant of breastfeeding
• Active concurrent malignancy
• Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
• Significant history of uncontrolled cardiac disease
• Uncontrolled seizure disorder, or active neurological disease
• Prior severe infusion reactions to a monoclonal antibody
• Prior chemotherapy regimen within 21 days prior to study entry
• Any EGFR tyrosine kinase inhibitor within 14 days of study entry
• Radiation therapy within 14 days prior to the first infusion of cetuximab
• Acute hepatitis or known HIV
• Active or uncontrolled infection
• Any concurrent chemotherapy or any other investigational agent(s)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Lecia V. Sequist

OTHER

Sponsor Role: lead

Responsible Party

Lecia V. Sequist

Overall PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lecia Sequist, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

Neal JW, Heist RS, Fidias P, Temel JS, Huberman M, Marcoux JP, Muzikansky A, Lynch TJ, Sequist LV. Cetuximab monotherapy in patients with advanced non-small cell lung cancer after prior epidermal growth factor receptor tyrosine kinase inhibitor therapy. J Thorac Oncol. 2010 Nov;5(11):1855-8. doi: 10.1097/JTO.0b013e3181f0bee0.

Reference Type: RESULT

PMID: 20975380 (View on PubMed)

Other Identifiers

06-026

Identifier Type: -

Identifier Source: org_study_id