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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00694603
• Other study ID #: 06-026
• Status: Terminated
• Phase: Phase 2
• First received: December 28, 2007
• Last updated: August 2, 2012
• Start date: September 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Cetuximab
Given intravenously once per week.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Lecia V. Sequist	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Bristol-Myers Squibb, Dana-Farber Cancer Institute, St. Joseph Hospital Health Center

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate by CT Scan Using RECIST Criteria		8 weeks	No
Secondary	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	No