| General information |
| Database: | DB00355 |
| Objective: | To evaluate the safety, pharmacokinetics, and efficacy of a chimeric antiepidermal growth factor receptor monoclonal antibody, cetuximab, in combination with radiation therapy (RT) in patients with advanced squamous cell carcinoma of the head and neck. |
| Authors: | Robert F, et al |
| Title: | Phase I study of antiepidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2001 |
| PMID: | 11432891 |
| 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: | 4 |
| Therapeutic Combination Content: | cetuximab + radiation therapy |
| Study Type: | Phase I study |
| Key Patients Feature: | patients with advanced head and neck cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | A standard dose escalation procedure was used; three patients entered onto the study at each dose level of cetuximab received conventional RT (70 Gy, 2 Gy/d), and the final three patients received hyperfractionated RT (76.8 Gy, 1.2 Gy bid). Cetuximab was delivered as a loading dose of 100 to 500 mg/m(2), followed by weekly infusions of 100 to 250 mg/m(2) for 7 to 8 weeks. Circulating levels of cetuximab during therapy were determined using a biomolecular interaction analysis core instrument. Human antichimeric antibody response was evaluated with a doubleantigen radiometric assay. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 16 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | All patients achieved an objective response (13 complete and two partial remissions). |
| 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): | The most commonly reported adverse events were fever, asthenia, transaminase elevation, nausea, and skin toxicities (grade 1 to 2 in most patients). Skin toxicity outside of the RT field was not strictly dosedependent; however, grade 2 or higher events were observed in patients treated with higher dose regimens. There was one grade 4 allergic reaction. Most acute adverse effects were associated with RT (xerostomia, mucositis, and local skin toxicity). |
| Conclusions: | Cetuximab can be safely administered with RT. The recommended dose forphase IIIII studies is a loading dose of 400 to 500 mg/m(2) and a maintenance weekly dose of 250 mg/m(2). |