Spots Global Cancer Trial Database for CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer

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Trial Identification

Brief Title: CALC-1 (Cetuximab in Advanced Lung Cancer): Study of 2 Methods of Combining Cetuximab and Gemcitabine in Patients With Advanced Non Small-cell Lung Cancer

Official Title: Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.

Study ID: NCT00330746

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

cetuximab

gemcitabine

cetuximab

Study Description

Brief Summary: The purpose of this study is to select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer, who are not candidates for platinum based therapy.

Detailed Description: The standard treatment for advanced non small cell lung cancer (NSCLC) is combination chemotherapy with cisplatin or carboplatin. Due to its toxicity, this therapy may not be suited for certain patients including the elderly, those whose general condition is poor. Combining chemotherapy with a biologic agent ("targeted therapy") is a new strategy being evaluated for the treatment of NSCLC, and cetuximab is one of the drugs that has shown promise for its activity and tolerability. This study aims to determine the more promising of 2 methods of combining gemcitabine with cetuximab (in combination vs. sequential administration), in two groups of patients who are not candidates for combination platinum based chemotherapy: patients under age 70 with performance status 2 (expected enrollment 42) , and patients over age 70 (expected enrollment 58). Patients will be randomly assigned to one of two treatment arms: * Arm A: Cetuximab + Gemcitabine: * Cetuximab given intravenously weekly AND * Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle) * Arm B: Gemcitabine followed by Cetuximab: * Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle) THEN * Cetuximab given intravenously weekly In Arm B, Cetuximab is administered as maintenance therapy when there has been an objective response to chemotherapy, or as second line therapy in patients who had disease progression during chemotherapy