Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cetuximab

Antimetabolites

Antineoplastic Agents, Immunological

gemcitabine followed by cetuximab (sequential)

400 mg/m2 first dose then weekly at 250 mg/m2 until disease progression

cetuximab

1200 mg/m2 days 1 and 8 every 3 weeks for a maximum of 6 cycles

gemcitabine

1200 mg/m2 IV days 1 and 8 every 3 weeks for a maximum of 6 cycles

400 mg/m2 first dose followed by 250 mg/m2 weekly

Cesare Gridelli, M.D.

Fortunato Ciardiello, M.D., Ph.D

Francesco Perrone, M.D., Ph.D

Ciro Gallo, M.D., Ph.D

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.

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

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT00330746	Advanced Non-Sm...	cetuximab gemcitabine gemcitabine cetuximab	18 Years -	National Cancer Institute, Naples
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	NCT00330746	Advanced Non-Sm...	cetuximab gemcitabine gemcitabine cetuximab	18 Years -	National Cancer Institute, Naples
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	NCT00330746	Advanced Non-Sm...	cetuximab gemcitabine gemcitabine cetuximab	18 Years -	National Cancer Institute, Naples

Spots Global Cancer Trial Database for one year survival