| General information |
| Database: | DB00411 |
| Objective: | Patients with advanced adenocarcinoma of the gastroesophageal junction/stomach are treated by combination chemotherapy, with minimal improvements in survival. they evaluated adding cetuximab to combination chemotherapy in these patients. |
| Authors: | Richards D, et al |
| Title: | Results of docetaxel plus oxaliplatin (DOCOX) ¡À cetuximab in patients with metastatic gastric and/or gastroesophageal junction adenocarcinoma: results of a randomisedphase 2 study. |
| Journal: | Eur J Cancer. |
| Year: | 2013 |
| PMID: | 23747051 |
| Trial Design |
| Clinical Trial Id: | NCT00517829 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | gastric cancer and esophagusgastroesophageal junction cancer |
| Cancer Subtype: | advanced adenocarcinoma of the stomach or gastroesophageal junction |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | docetaxel plus oxaliplatin (DOCOX) ¡À cetuximab |
| Study Type: | Phase II, openlabel, randomised, noncomparative study, |
| Key Patients Feature: | male or female patientsP18 years old with histologically confirmed measurableStage IV adenocarcinoma of the gastroesophageal junction/stomach. patients were allowed to have had adjuvant radiation plus treatment with 5fluorouracil andleucovorin. This trial was amended to request thatpatients have tissue available (minimum five unstainedslides and one representative haematoxylin & eosinstained slide or block) for analysis of KRAS mutation.Patients without tissue were eligible; however, everyeffort was made to secure tissue from patients with available samples. Other inclusion criteria were EasternCooperative Group (ECOG) Performance Status (PS)0-2, and 6Grade 1 preexisting (current) peripheral neuropathy |
| Biomarker: | KRAS status |
| Biomark Analysis: | KRAS was collected on some patients 2 years into the study because of new American Society of Clinical Oncology (ASCO) findings. |
| Control Group Info: | Arm 1: docetaxel+oxaliplatin (DOCOX)=docetaxel 60 mg/m(2) plus oxaliplatin 130 mg/m(2) on Day 1 of each 21day cycle. Arm 2: docetaxel+oxaliplatin+cetuximab (DOCOX+C)=DOCOX with C 400mg/m(2) first dose then 250 mg/m(2) weekly |
| Treatment Info: | Treatment Arm 1: docetaxel+oxaliplatin (DOCOX)=docetaxel 60 mg/m(2) plus oxaliplatin 130 mg/m(2) on Day 1 of each 21day cycle. Arm 2: docetaxel+oxaliplatin+cetuximab (DOCOX+C)=DOCOX with C 400mg/m(2) first dose then 250 mg/m(2) weekly. |
| Primary End Point: | progression free survival. |
| Secondary End Point: | response rate, time to response, duration of response and safety. |
| Patients Number: | 150 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Response rate/arm: 26.5%/38.0% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | DOCOX/DOCOX + C: 4.7/5.1 months (95% confidence interval (CI) 3.0- 5.6/4.3-5.9) |
| Median OS A vs. C: | DOCOX/DOCOX + C: 1 year survival: 39.1%/33.0%, median overall survival: 8.5/9.4 months |
| Adverse Event(agent arm): | Grade 3-4 treatmentrelated adverse events (%) included neutropenia (50%/44%), febrile neutropenia (13%/19%), diarrhoea (12%/17%), fatigue (12%/17%) and leukopenia (7%/14%). Discontinuation was due to progressive disease 39/32 and adverse events 21/34. |
| Conclusions: | Cetuximab added to DOCOX may improve response rate minimally; there appears to be no improvement in progression free survival, overall survival or 1year survival. Cetuximab added to DOCOX did not produce clinically significant outcomes. Toxicities they were consistent with the study drugs' known safety profiles. KRAS mutation was infrequent; no conclusions can be drawn from KRAS response data. ClinicalTrial.gov Identifier?NCT00517829. |