| General information |
| Database: | DB00330 |
| Objective: | The aim of the present study was to identify a potentially effective new treatment regimen for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in disease progression after at least two previous chemotherapy regimens. |
| Authors: | Massa E, et al |
| Title: | Phase II study of vinorelbine/cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck progressing after at least two chemotherapy regimens. |
| Journal: | Oral Oncol. |
| Year: | 2010 |
| PMID: | 20920877 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | concurrent chemotherapy and cetuximab versus chemotherapy followed by cetuximab |
| Study Type: | phase II, open, nonrandomized trial |
| Key Patients Feature: | patients wereconsidered eligible if they were P18 < 75 years of age with EasternCooperative Oncology Group10 (ECOG) performance status (PS) 0-2 and P75 years with ECOG PS 0-1, with recurrent and/or metastatic histologically confirmed SCCHN (excluding nasopharyngealcancer) with progressive disease after at least two chemotherapyregimens one of which platinumbased; had measurable metastatic lesion(s) as assessed by the Response Evaluation Criteria inSolid Tumors (RECIST)11; an ECOG (PS) score of 0-2, adequatehematologic (absolute neutrophil count >1.5 109 L 1, plateletcount >100 109 L 1, haemoglobin levels >10 g/dL), hepatic (bilirubin 61.5 mg/dL, SGOT or SGPT 6 two times upper limits of normal) and renal (creatinine <1.4 mg/dL) function; life expectancy>3 months. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | The "novel" regimen was Cetuximab administered weekly plus Vinorelbine on days 1, 8, 15 every 28 days. The regimen was administered to patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck previously treated with surgery, radiotherapy or both and progressing after at least two chemotherapy regimens. |
| Primary End Point: | identifying a potentially effective and feasible regimen |
| Secondary End Point: | NA |
| Patients Number: | 23 |
| Trial Results |
| DLT_MTD: | The worst adverse events (AEs) per patient are reported in Table4. The most common hematologic AEs were: grade 4 neutropeniain 2 patients (8.3%) and grade 3 anemia in 4 patients (16.7%); grade4 and grade 3 skin reaction in two (8.3%) and three (12.5%) patients, respectively; grade 3 peripheral neuropathy in one patient(4.2%). |
| Objective Response Rate: | 23 patients(95.8%) were evaluable for response: 4 patients had partial response; 12 stable disease and 7 progressivedisease. Disease control rate was 69.5%. |
| Disease Control Rate: | 0.695 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.8 months |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common hematologic AEs were: grade 4 neutropenia in 2 patients (8.3%) and grade 3 anemia in 4 patients (16.7%); grade 4 and grade 3 skin reaction in two (8.3%) and three (12.5%) patients, respectively; grade 3 peripheral neuropathy in one patient (4.2%). |
| Conclusions: | The present study shows that the combination of Vinorelbine and Cetuximab in recurrent andor metastatic squamous cell carcinoma of the head and neck patients is effective, feasible and has a good safety profile. Our findings warrant further investigation in a wider patient population. |