| General information |
| Database: | DB00280 |
| Objective: | Platinum/5fluorouracil plus cetuximab is a standard systemic treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Pemetrexed has shown activity in SCCHN. Thisphase II study evaluated pemetrexed with cisplatin and cetuximab in recurrent/metastatic SCCHN. |
| Authors: | Vermorken JB, et al |
| Title: | Phase II study of pemetrexed in combination with cisplatin and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck. |
| Journal: | Eur J Cancer. |
| Year: | 2013 |
| PMID: | 23726971 |
| Trial Design |
| Clinical Trial Id: | NCT01057589 |
| 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: | pemetrexed+cisplatin+cetuximab |
| Study Type: | a multicentre, openlabel, singlearm study |
| Key Patients Feature: | histologicallyconfirmed diagnosis of SCCHN, locoregionally recurrent and/or metastatic disease not amenable to local therapy, ECOG PS of 0-1, adequate organ function and age 18 years |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received cetuximab 250 mg/m(2) (loading dose: 400mg/m(2))days 1, 8 and 15; pemetrexed 500 mg/m(2)+cisplatin 75 mg/m(2) on day 1, q3w up to six cycles and folic acid, vitamin B12 and prophylactic medications. After a minimum of four cycles, responding patients were eligible for maintenance with pemetrexed and cetuximab, or either as monotherapy, until progression or toxicity. |
| Primary End Point: | PFS. |
| Secondary End Point: | estimation of OS, assessment of objective response rate (ORR) and evaluation of safety and toxicity. |
| Patients Number: | 66 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Objective response rate was 29.3% |
| Disease Control Rate: | 23 patients had stable disease (39.7%) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.4 months (95% confidence interval [CI]: 3.6, 5.4) |
| Median OS A vs. C: | 9.7 months (95% CI: 6.5, 13.1) |
| Adverse Event(agent arm): | Drugrelated grade 3/4 toxicities included neutropaenia (33.3%), fatigue (24.2%), anorexia (12.1%) and infection (10.6%). Five treatmentrelated deaths (7.6%) occurred. |
| Conclusions: | Efficacy results they were consistent with current standard treatment for this patient population, but the prespecified mPFS of 5.5 months was not achieved. Grade 34 toxicities they were also consistent with standard treatment, although treatmentrelated deaths they were higher than expected. |