| General information |
| Database: | DB00798 |
| Objective: | Cetuximab, an immunoglobulin (Ig) G1 chimeric monoclonal antibody against the epidermal growth factor receptor, has demonstrated evidence of activity in nonsmall cell lung cancer (non small cell lung cancer). When administered in combination with carboplatin and docetaxel, a commonly used regimen for advanced non small cell lung cancer, cetuximab has exhibited synergistic interaction in preclinical studies. Therefore, a phase 2 study was conducted to evaluate the efficacy of the combination of cetuximab, carboplatin, and docetaxel for the treatment of advanced non small cell lung cancer. |
| Authors: | Belani CP, et al |
| Title: | Cetuximab in combination with carboplatin and docetaxel for patients with metastatic or advancedstage nonsmall cell lung cancer: a multicenterphase 2 study. |
| Journal: | Cancer. |
| Year: | 2008 |
| PMID: | 18816622 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | Cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Cetuximab + carboplatin + docetaxel |
| Study Type: | a multicenterphase II study. |
| Key Patients Feature: | Chemotherapyna ve patients aged >or=18 years with stage IIIB (with effusion) or stage IV non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received cetuximab (at a dose of 400 mg/m(2) on Day 1 and 250 mg/m(2) on Days 8 and 15) plus docetaxel (at a dose of 75 mg/m(2) on Day 1) and carboplatin (area under the concentration vs time curve [AUC]=6 on Day 1) every 21 days for up to 6 cycles (graded according to the American Joint Committee on Cancer Staging System). Thereafter, patients without evidence of disease progression were continued on singleagent cetuximab for a maximum of 1 year or until disease progression |
| Primary End Point: | response rate. |
| Secondary End Point: | NA |
| Patients Number: | 80 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 15.20% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.6 months |
| Median OS A vs. C: | 10.3 months |
| Adverse Event(agent arm): | NA |
| Conclusions: | The results of this large, multicenter,phase 3 study indicate that the novel combination of cetuximab with docetaxel and carboplatin demonstrate modest anticancer activity for patients with advanced and metastatic non small cell lung cancer and has an acceptable toxicity profile. |