| General information |
| Database: | DB00308 |
| Objective: | Cholangiocarcinomas are uncommon tumours with a poor prognosis, that frequently present epidermal growth factor receptor overexpression. |
| Authors: | Borbath I, et al |
| Title: | Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23975665 |
| Trial Design |
| Clinical Trial Id: | NCT00747097 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | biliary tract and gallbladder cancer |
| Cancer Subtype: | advanced cholangiocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine+ cetuximab |
| Study Type: | a phase II study of the Belgian Group of Digestive Oncology |
| Key Patients Feature: | All patients had a histologically or cytologically confirmed CCK; measurable disease according to RECIST, ECOG performance status (PS) 0 or 1; estimated life expectancy more than and equal to 12 weeks; adequate liver (total bilirubin less than and equal to 2¡Á the upper limit of normal (ULN) range); renal (serum creatinin <1.5¡Á ULN range) and haematopoietic (Hb >9 g/dl, absolute neutrophil count >1.500/mm3 and platelets >100 000/mm3) functions. All patients with jaundice underwent an adequate bile duct drainage. |
| Biomarker: | KRAS mutational status |
| Biomark Analysis: | KRAS mutations were found in 7 of 27 patients and had no influence on PFS. Skin toxic effect more than and equal to grade 2 was associated with increased PFS (P = 0.05). |
| Control Group Info: | single arm |
| Treatment Info: | patients with unresectable cholangiocarcinoma, na ve to chemotherapy, received Cetuximab (400 mg/m(2) at week 1, then 250 mg/m(2)/week) and Gemcitabine (1 g/m(2) on day 1, 8 and 15 every 4 weeks). |
| Primary End Point: | The primary objective of this trial was the PFS rate at 6 months |
| Secondary End Point: | OS, response rate and safety. Exploratory objectives were to assess relationship between KRAS mutational status and skin toxic effect with PFS and OS outcomes. |
| Patients Number: | 44 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Nine patients (20.4%) had PR |
| Disease Control Rate: | 0.795 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Six months PFS reached 47% |
| Median OS A vs. C: | 13.5 months [95% (CI) 9.831.8 months]. |
| Adverse Event(agent arm): | Grade 3/4related toxic effects were haematological (52.2%), skin rash (13.6%) and fatigue (11.4%). |
| Conclusions: | Our study met its primary end point, suggesting that GemcitabineCetuximab has activity in cholangiocarcinoma. KRAS status was not associated with PFS, unlike skin toxic effect, which could be used as a surrogate marker for efficacy. |