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Sponsors and Collaborators: |
Veeda Oncology Bristol-Myers Squibb |
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Information provided by: | Veeda Oncology |
ClinicalTrials.gov Identifier: | NCT00251498 |
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:
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.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer |
Enrollment: | 82 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | I-04-002 |
Study First Received: | November 8, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00251498 |
Health Authority: | United States: Food and Drug Administration |
Metastatic 1st line NSCLC |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Cetuximab Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |