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

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
St. Joseph Hospital Health Center
Bristol-Myers Squibb
Information provided by (Responsible Party):
Lecia V. Sequist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00694603
First received: December 28, 2007
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Cetuximab
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Response Rate by CT Scan Using RECIST Criteria [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
400mg/m2 IV x 1 and then 250mg/m2 IV weekly
Drug: Cetuximab
Given intravenously once per week.
Other Name: Erbitux

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694603

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Lecia V. Sequist
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
St. Joseph Hospital Health Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Lecia Sequist, MD, MPH Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Lecia V. Sequist, Overall PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00694603     History of Changes
Other Study ID Numbers: 06-026
Study First Received: December 28, 2007
Results First Received: April 28, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
cetuximab
tyrosine kinase inhibitor

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014