Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
The primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced non-small cell lung cancer.
The secondary objectives of this study are:
- to determine the time to progression and overall survival for patients with advanced NSCLC who are treated with the combination docetaxel, carboplatin , and cetuximab
- to determine the toxicity of the combination in patients with advanced NSCLC.
Patients with stages IIIB (pleural or pericardial effusion) and IV NSCLC who have not received any prior chemotherapy will be eligible to participate in the trial. Other eligibility criteria include: ECOG PS 0-1, normal hepatic and renal function, age >18 years. Specific inclusion and exclusion criteria are detailed in Sections 4.2 and 4.3.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer|
|Study Completion Date:||October 2007|
This is a phase II, open label, non-randomized study in patients with histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC who have not received prior chemotherapy. The trial will evaluate the efficacy and safety profile of the combination of docetaxel, carboplatin and cetuximab for patients with advanced NSCLC.
Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks plus cetuximab given weekly. A maximum of four cycles of chemotherapy will be administered to patients. Patients who demonstrate an ongoing response (CR/PR/SD) at the end of 4th cycle of chemotherapy, may receive two more cycles of treatment. Patients who continue to respond (CR/PR/SD) after six cycles of therapy may receive therapy with single agent cetuximab (250 mg/m2/week) for up to 1 year or until disease progression or unacceptable toxicity, whichever occurs first.
Patients will be evaluated for response, time to progression, and overall survival. In addition, the safety profile of the combination will be assessed.