| General information |
| Database: | DB00426 |
| Objective: | The purpose of thisphase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a firstline treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. |
| Authors: | Pinto C, et al |
| Title: | Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). |
| Journal: | Ann Oncol. |
| Year: | 2007 |
| PMID: | 17164226 |
| 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 + FOLFIRI |
| Study Type: | multicenterphase II study |
| Key Patients Feature: | Patients with advanced, unresectable, histologically confirmedadenocarcinoma of the stomach or GEJ were assessed for eligibility.Eligibility criteria were age 18 years, Karnofsky performance status (KPS) 70, life expectancy 3 months, no previous treatment with chemotherapyor radiation therapy, neutrophil count 1500/ll, platelet count 100.000/ll, hemoglobin 9.0 g/dl, serum creatinine ¡ê1.5 . upper limit of normal(ULN), alanine aminotransferase and aspartate aminotransferase ¡ê2.5 .ULN (¡ê5 . ULN in the presence of liver metastases), total bilirubin ¡ê1.5 .ULN, EGFR expression in primary, and/or metastatic tumor demonstratedby immunohistochemistry, measurable disease according to the responseevaluation criteria in solid tumors (RECIST) [26]. Prior chemotherapy foradvanced cancer was not allowed. Patients who received adjuvant therapywere eligible provided >6 months had relapsed between the end of adjuvanttherapy and registration on 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) intravenously (i.v.) followed by weekly doses of 250 mg/m(2), CPT 11 180 mg/m(2) i.v. on day 1, LFA 100 mg/m(2) i.v. followed by 5FU 400 mg/m(2) i.v. bolus, and 600 mg/m(2) i.v. 22h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks. |
| Primary End Point: | objective response. |
| Secondary End Point: | toxicity, median survival, and TTP. |
| Patients Number: | 38 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Fourpatients (11.8%) achieved a complete response and 11 patients(32.4%) a partial response; the ORR was 44.1% (95% CI 27.5%to 60.9%). Sixteen patients (47.1%) had stable disease and threepatients (8.8%) progressive disease. The disease control(complete response plus partial response plus stable disease) was91.2%. |
| Disease Control Rate: | 0.912 |
| Median Time to Progression: | 8 months (95% CI7-9) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | The median OS time estimated in all 38 patients is 16 months (95% CI 9-23) |
| Adverse Event(agent arm): | The major toxicity observed was hematological. Grade 3-4 neutropenia occurred in 16 patients (42.1%). Febrile neutropenia occurred in two patients (5.3%) and one of them died of febrile neutropenia after the first week¡¯s therapy. Nonhematological toxic effects were generally mild in severity. The most common grade 3-4 nonhematological toxic effects were diarrhea (7.9%), asthenia (5.3%), stomatitis (5.3%), hypertransaminasemia (5.3%), and vomiting (2.6%). |
| Conclusions: | The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia. |