| General information |
| Database: | DB00342 |
| Objective: | To determine the feasibility and toxicity of the addition of cetuximab to paclitaxel, carboplatin, and concurrent radiation for patients with head and neck cancer. |
| Authors: | Birnbaum A, et al |
| Title: | Cetuximab, paclitaxel, carboplatin, and radiation for head and neck cancer: a toxicity analysis. |
| Journal: | Am J Clin Oncol. |
| Year: | 2010 |
| PMID: | 19786848 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Cetuximab, paclitaxel, carboplatin, and radiation |
| Study Type: | prospectivephase II study |
| Key Patients Feature: | Eligible patientsincluded those with stage III or IV, locally advanced SCCHN.Patients with metastatic disease to other organs or noncervical, distant lymph nodes were ineligible. Required laboratory parametersincluded granulocyte count 1, 800 cells/ L, Hgb 9 g/dL, plateletcount 100, 000 cells/ L, bilirubin 1.3 institutional upper limitof normal, AST 2.5 ULN, creatinine 1.5 upper limit ofnormal, and creatinine clearance 30 mL/min (using the CockcraftGault Formula). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received 4 weeks of induction cetuximab followed by weekly cetuximab, paclitaxel, carboplatin, and concurrent radiation. |
| Primary End Point: | feasibility and toxicity |
| Secondary End Point: | NA |
| Patients Number: | 32 |
| Trial Results |
| DLT_MTD: | Grade 3 and grade 4 mucositis occurred in 53% and 16% of patients, respectively. Grade 3 and grade 4 radiation dermatitis occurred in 44% and9% of patients, respectively. Grade 3/4 radiation dermatitis was associatedwith the use of intensity modulated radiation therapy (64% vs.14%, respectively, P 0.0001). Grade 3 and grade 4 cetuximab associated acneiformrash developed in 6% and 3% of patients. Overall 21 patients (66%) had anygrade 3 toxicity and 10 patients (31%) had any grade 4 toxicity. Thepercentages of the intended total dose delivered of carboplatin, cetuximab, paclitaxel, and radiation were 86%, 89%, 89%, and 96%, respectively. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Grade 3 and grade 4 mucositis occurred in 53% and 16% of patients, respectively. Grade 3 and grade 4 radiation dermatitis occurred in 44% and 9% of patients, respectively. Grade 3/4 radiation dermatitis was associated with the use of intensity modulated radiation therapy (64% vs.14%, respectively, P < 0.0001). Grade 3 and grade 4 cetuximab associated acneiform rash developed in 6% and 3% of patients. Overall 21 patients (66%) had any grade 3 toxicity and 10 patients (31%) had any grade 4 toxicity. |
| Conclusions: | Cetuximab, when combined with paclitaxel, carboplatin and intensity modulated radiation therapy, increases dermatologic toxicity but does not increase mucosal toxicity as compared with previous Brown University Oncology Group studies of paclitaxel, carboplatin, and conventional radiation for patients with head and neck cancer. |