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Sponsors and Collaborators: |
University of Chicago Bristol-Myers Squibb |
Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00203931 |
The purpose of the study is to determine in patients with Non Small Cell Lung Cancer refractory to previous chemotherapy whether concomitant treatment with cetuximab and pemetrexed improves progression-free survival compared with cetuximab monotherapy.
Condition | Intervention | Phase |
Non-Small Cell Lung Cancer |
Drug: Cetuximab Drug: Cetuximab and Pemetrexed |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Pemetrexed disodium Pemetrexed Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial Comparing Cetuximab With Concurrent Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer Refractory to Primary Treatment |
Estimated Enrollment: | 80 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | July 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A - Cetuximab: Experimental |
Drug: Cetuximab
Cetuximab every week by vein
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B: Experimental |
Drug: Cetuximab and Pemetrexed
Cetuximab and Pemetrexed
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |||||
The University of Chicago | |||||
Chicago, Illinois, United States, 60637 |
University of Chicago |
Bristol-Myers Squibb |
Principal Investigator: | Everett Vokes, M.D. | University of Chicago |
Responsible Party: | The University of Chicago ( Michael Maitland, MD ) |
Study ID Numbers: | 13722A |
First Received: | September 12, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00203931 |
Health Authority: | United States: Institutional Review Board |
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