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| Sponsors and Collaborators: |
ImClone Systems University of Colorado at Denver and Health Sciences Center Greenwich Hospital IUPUI, Indianapolis, IN |
| Information provided by: | ImClone Systems |
| ClinicalTrials.gov Identifier: | NCT00034541 |
Purpose
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 |
|
Carcinoma, Non-Small-Cell Lung |
Drug: cetuximab |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Carboplatin Paclitaxel Cetuximab Epidermal Growth Factor |
| 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 |
| Estimated Enrollment: | 33 |
| Study Start Date: | December 2000 |
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.
Eligibility
| 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:
Exclusion Criteria:
The following ten exclusion criteria are for this study:
Contacts and Locations| 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 | |||||
| ImClone Systems |
| University of Colorado at Denver and Health Sciences Center |
| Greenwich Hospital |
| IUPUI, Indianapolis, IN |
More Information
| Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
| Study ID Numbers: | CP02-9932 |
| First Received: | April 30, 2002 |
| Last Updated: | October 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00034541 |
| Health Authority: | United States: Food and Drug Administration |
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