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Sponsors and Collaborators: |
ImClone LLC University of Colorado at Denver and Health Sciences Center Greenwich Hospital IUPUI, Indianapolis, IN |
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Information provided by: | ImClone LLC |
ClinicalTrials.gov Identifier: | NCT00034541 |
The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Biological: cetuximab Drug: paclitaxel Drug: carboplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer |
Enrollment: | 32 |
Study Start Date: | December 2000 |
Study Completion Date: | May 2003 |
Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
An initial dose of cetuximab (400 mg/m2 i.v. over 120 minutes) will be administered 1 week prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly at maintenance doses of 250 mg/m2 (over 60 minutes). On the first day of each cycle (every 3 weeks) of therapy, a 3-hour paclitaxel (225 mg/m2) infusion will be administered 1-hour post completion of the cetuximab infusion, immediately followed by a 30-minute carboplatin (AUC=6) infusion.
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Biological: cetuximab
400 mg/m2 i.v. over 120 minutes
Drug: paclitaxel
225 mg/m2, infusion
Drug: carboplatin
30-minute AUC = 6, infusion.
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The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy. Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met. An initial dose of cetuximab will be administered prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion, immediately followed by a carboplatin infusion. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following inclusion criteria must be met:
The patient has adequate renal function with a serum creatinine level ≤1.5 mg/dL or a creatinine clearance
Exclusion Criteria:
The following ten exclusion criteria are for this study:
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Connecticut | |
Greenwich Hospital | |
Greenwich, Connecticut, United States, 06830 | |
United States, Indiana | |
IUPUI | |
Indianapolis, Indiana, United States, 46202 |
Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP02-9932 |
Study First Received: | April 30, 2002 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00034541 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cetuximab epidermal growth factor receptor antibody |
non-small cell lung cancer carboplatin paclitaxel |
Thoracic Neoplasms Cetuximab Antimitotic Agents Carboplatin Carcinoma Antibodies Respiratory Tract Diseases Lung Neoplasms Paclitaxel |
Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Mitogens Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Immunoglobulins Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Cetuximab Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Paclitaxel Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |