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

NCT00694603 | Terminated Phase 2 Results DMC

• 1 other identifier: 06-026
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-small Cell Lung Cancer

Keywords

cetuximab; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Response Rate by CT Scan Using RECIST Criteria

  8 weeks

Secondary Outcomes (1)

• Progression-free Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Study Arms (1)

Cetuximab

EXPERIMENTAL

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

Drug: Cetuximab

Interventions

Cetuximab DRUG

Given intravenously once per week.

Also known as: Erbitux

Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lecia V. Sequist: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Unity Health Toronto: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 20975380 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Lecia Sequist
• Organization: Massachusetts General Hospital

lvsequist@partners.org

617-724-4000

Study Officials

• Lecia Sequist, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Overall PI

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: June 10, 2008
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 6, 2012
• Results First Posted: September 6, 2012

Record last verified: 2012-08

Locations

US (3)