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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
Lecia V. Sequist
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring cetuximab, tyrosine kinase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab

Arm Description

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

Outcomes

Primary Outcome Measures

Response Rate by CT Scan Using RECIST Criteria

Secondary Outcome Measures

Progression-free Survival

Full Information

First Posted
December 28, 2007
Last Updated
August 2, 2012
Sponsor
Lecia V. Sequist
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Unity Health Toronto, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00694603
Brief Title
Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lecia V. Sequist
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Unity Health Toronto, Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
cetuximab, tyrosine kinase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab
Arm Type
Experimental
Arm Description
400mg/m2 IV x 1 and then 250mg/m2 IV weekly
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Given intravenously once per week.
Primary Outcome Measure Information:
Title
Response Rate by CT Scan Using RECIST Criteria
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lecia Sequist, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20975380
Citation
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.
Results Reference
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Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy

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