| General information |
| Database: | DB00418 |
| Objective: | he purpose of thisphase II trial was to evaluate the efficacy and safety of cetuximab and irinotecan as secondline treatment in patients with gastrooesophageal adenocarcinoma. |
| Authors: | Sch nnemann KR, et al |
| Title: | Phase II study of biweekly cetuximab in combination with irinotecan as secondline treatment in patients with platinumresistant gastrooesophageal cancer. |
| Journal: | Eur J Cancer. |
| Year: | 2012 |
| PMID: | 22244801 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer and esophagusgastroesophageal junction cancer |
| Cancer Subtype: | adenocarcinoma of the lower oesophagus, oesophagealjunction or stomach |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | biweekly cetuximab + irinotecan |
| Study Type: | phase II study |
| Key Patients Feature: | The study included patients with histological confirmed, evaluable or nonevaluable, nonresectable ormetastatic adenocarcinoma of the lotheyr oesophagus, oesophagealjunction or stomach. All patients hadreceived prior platinumbased chemotherapy and demonstrated progressive disease after or during previoustreatment. The eligibility requirements included a PSof 0-1; age >18 years and a life expectancy of at least12 weeks. Preclinical laboratory parameters includedan adequate bone marrow function (neutrophils>1.5 109/L, platelets >100 109/L); adequate hepatic function (serum bilirubin <1.5 upper normallimit (UNL), in case of liver metastases, there wereno upper limit for transaminases) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients with failure to firstline platinumbased chemotherapy received cetuximab 500 mg/m(2) and irinotecan 180 mg/m(2) every second week until disease progression. Toxicity was evaluated according to The Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) v. 3.0. Antitumour activity was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v. 1.0. |
| Primary End Point: | RR |
| Secondary End Point: | PFS and OS |
| Patients Number: | 63 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Response rate was 11% (6 partial response (PR)) and 37% had stable disease. |
| Disease Control Rate: | 0.48 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.8 months(Confidence interval 1.8-3.5) |
| Median OS A vs. C: | 6.1 months (CI 4.5-7.1) |
| Adverse Event(agent arm): | Grade 3-4 toxicity included: diarrhoea (6%), fatigue (5%), vomiting (5%) and neutropenia (16%). Two patients developed febrile neutropenia. Fortysix patients (73%) haddeveloped grade 1-2 skin rash. |
| Conclusions: | The combination of cetuximab and irinotecan is active as secondline therapy in patients with gastrooesophageal cancer. Cetuximab induced skin rash was associated with prolonged survival. |