- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00063388
Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer
April 8, 2010 updated by: Eli Lilly and Company
A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
Determine tumor response rate and time to disease progression, survival and safety in total populations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Aventura, Florida, United States, 33180
- ImClone Investigational Site
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Miami Beach, Florida, United States, 33140
- ImClone Investigational Site
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Illinois
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Chicago, Illinois, United States, 60612
- ImClone Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46202
- ImClone Investigational Site
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South Bend, Indiana, United States, 46601
- ImClone Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- ImClone Investigational Site
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Boston, Massachusetts, United States, 02115
- ImClone Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- ImClone Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
- Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
- Unidimensionally measurable NSCLC
- Subjects with tumor tissue available for EGFR assessment
- ECOG performance status of 0 or 1
- Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids
Exclusion Criteria
- Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
- Women of childbearing potential using a prohibited contraceptive method
- Women who were pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
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Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
Time Frame: Every 8 weeks
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Every 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the tumor response rate in the total population and in EGFR- subjects
Time Frame: Every 8 weeks
|
Every 8 weeks
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Time to disease progression in the EGFR+ and total populations.
Time Frame: Every 8 weeks
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Every 8 weeks
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Survival in the EGFR+ and total populations.
Time Frame: Every 8 weeks
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Every 8 weeks
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Safety in the EGFR+ and total populations.
Time Frame: Every 8 weeks
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Every 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
June 25, 2003
First Submitted That Met QC Criteria
June 26, 2003
First Posted (Estimate)
June 27, 2003
Study Record Updates
Last Update Posted (Estimate)
April 12, 2010
Last Update Submitted That Met QC Criteria
April 8, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA225-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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