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Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

2014-08-27 03:56:12 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention

cetuximab, paclitaxel, carboplatin

Location

ImClone Investigational Site
Denver
Colorado
United States
80262

Status

Completed

Source

ImClone LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:12-0400

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

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