| General information |
| Database: | DB00424 |
| Objective: | The conventional treatment options for advanced gastric patients remain unsatisfactory in terms of response rate, response duration, toxicity, and overall survival benefit. The purpose of thisphase II study was to evaluate the activity and safety of cetuximab combined with cisplatin and docetaxel as a firstline treatment for advanced gastric or gastrooesophageal junction adenocarcinoma. |
| Authors: | Pinto C, et al |
| Title: | Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastrooesophageal junction adenocarcinoma (DOCETUX study). |
| Journal: | Br J Cancer. |
| Year: | 2009 |
| PMID: | 19773760 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | adenocarcinoma of the stomach or GEJ(gastroesophageal junction) |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab + cisplatin and docetaxel |
| Study Type: | multicentrephase II study |
| Key Patients Feature: | atients with advanced, unresectable, histologically confirmedadenocarcinoma of the stomach or GEJ were assessed foreligibility. The eligibility criteria were: age X18 years, Karnofskyperformance status (KPS) X70, life expectancy 43 months, noearlier treatment with chemotherapy or radiation therapy, neutrophil count X1500 per ml, platelet count X100.000 per ml, haemoglobin X9.0gdl 1, serum creatinine p1.5 upper limit ofnormal (ULN), ALT and AST p2.5 ULN (p5 ULN in thepresence of liver metastases), total bilirubin p1.5 ULN, measurable disease according to the Response Evaluation Criteria in SolidTumours (RECIST) (Therasse et al, 2000). atients who received adjuvanttherapy were eligible provided more than 6 months had elapsedbetween the end of adjuvant therapy and registration for the study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received cetuximab at an initial dose of 400 mg m(2) i.v. followed by weekly doses of 250 mg m(2), cisplatin 75 mg m(2) i.v. on day 1, docetaxel 75 mg m(2) i.v. on day 1, every 3 weeks, for a maximum of 6 cycles, and then cetuximab maintenance treatment was allowed in patients with a complete response, partial response, or stable disease. |
| Primary End Point: | objective response (ORR). |
| Secondary End Point: | toxicity, median survival time (OS), and time to progression (TTP). |
| Patients Number: | 72 |
| Trial Results |
| DLT_MTD: | The most frequent grades 3-4 toxicity was neutropenia (44.4%).No toxic death was observed |
| Objective Response Rate: | The ORR was 41.2% (95% CI, 29.5-52.9). Median time to progression was 5 months (95% CI, 3.7-5.4). Median survival time was 9 months (95% CI, 7-11). |
| Disease Control Rate: | 0.765 |
| Median Time to Progression: | 5 months (95% CI, 3.7-5.4) |
| Median PFS A vs. C: | 5 months (95% CI, 3.7-5.4). |
| Median OS A vs. C: | 9 months (95% CI, 7-11) |
| Adverse Event(agent arm): | The most frequent grades 3-4 toxicity was neutropenia (44.4%). No toxic death was observed. |
| Conclusions: | The addition of cetuximab to the cisplatindocetaxel regimen improved the ORR of the cisplatindocetaxel doublet in the firstline treatment of advanced gastric and gastrooesophageal junction adenocarcinoma, but this combination did not improve the TTP and OS. The toxicity of cisplatindocetaxel chemotherapy was not affected by the addition of cetuximab. |