| General information |
| Database: | DB00285 |
| Objective: | Cetuximab and docetaxel have singleagent activity in squamous cell carcinoma of the head and neck (SCCHN). The efficacy of their combination was evaluated in platinumpretreated patients with recurrent and/or metastatic SCCHN. |
| Authors: | Knoedler M, et al |
| Title: | Phase II study of cetuximab in combination with docetaxel in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck after platinumcontaining therapy: a multicenter study of the Arbeitsgemeinschaft Internistische Onkologie. |
| Journal: | Oncology. |
| Year: | 2013 |
| PMID: | 23445718 |
| 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: | 2 |
| Therapeutic Combination Content: | cetuximab +docetaxel |
| Study Type: | an openlabel, uncontrolled, interdisciplinary, multicenter, phase II study |
| Key Patients Feature: | patients were eligible if they were 18 years of age or older and had histologically or cytologically confirmed incurable recurrent and/or metastatic SCCHN. Other inclusion criteria included prior platinumcontaining chemotherapy; at least one lesion being measurable according to RECIST criteria 1.1, a Karnofsky performance score (KPS) more than and equal to 70%, and adequate hematologic, renal and hepatic function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with docetaxel 35 mg/m(2) weekly for a maximum of 6 cycles and concomitant cetuximab 250 mg/m(2) weekly until disease progression or unacceptable toxicity. |
| Primary End Point: | the objective response rate |
| Secondary End Point: | the response rate in relation to platinum sensitivity, progression free survival (PFS), overall survival (OS) and toxicity. |
| Patients Number: | 84 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Nine (11%) patients achieved a partial response and 34 (40%) stable disease; Response to treatment was 49% in previously platinumsensitive and 50% in previously platinumresistant disease. |
| Disease Control Rate: | 0.51 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.1 months |
| Median OS A vs. C: | 6.7 months |
| Adverse Event(agent arm): | The most common grade 3 or 4 adverse events were mucositis (8%), pneumonia (8%), fatigue (8%) and skin reactions (14%). Sepsis occurred in 3 patients. |
| Conclusions: | Cetuximab plus docetaxel is an active treatment regimen with moderate toxicity in SCCHN patients. Hotheyver, no superiority in comparison with monotherapy could be shown. Responsiveness and survival they were independent of previous platinum sensitivity. |