| General information |
| Database: | DB00908 |
| Objective: | Previousphase 2 studies have shown antitumour activity with gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliarytract cancers (BTCs). In thisphase 2 study, they assessed the efficacy and safety of combined bevacizumab with GEMOX (GEMOXB) in patients with advanced BTCs, and investigated how changes in 18fluorodeoxyglucose ([(18)F]FDG)PET correlate with clinical outcome |
| Authors: | Zhu AX, et al |
| Title: | Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliarytract cancers and correlation of changes in 18fluorodeoxyglucose PET with clinical outcome: a phase 2 study. |
| Journal: | Lancet Oncol. |
| Year: | 2010 |
| PMID: | 19932054 |
| Trial Design |
| Clinical Trial Id: | NCT00361231 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | biliary tract and gallbladder cancer |
| Cancer Subtype: | advanced biliarytract cancers |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine, oxaliplatin, + bevacizumab |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with advanced measurable BTCs(biliarytract cancers ) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients were given the following treatment on days 1 and 15 of a 28day cycle: bevacizumab 10 mg/kg, followed by gemcitabine 1000 mg/m(2) (10 mg/m(2) per min) and oxaliplatin 85 mg/m(2) (2h infusion). |
| Primary End Point: | progression free survival (PFS). Efficacy and safety analyses were by intention to treat. |
| Secondary End Point: | NA |
| Patients Number: | 35 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 40% |
| Disease Control Rate: | 69% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.0 months (95% CI 5.310.3) |
| Median OS A vs. C: | 12.7 months (95% CI 7.3-18.1) |
| Adverse Event(agent arm): | GEMOXB was generally well tolerated; the most common adverse events included fatigue, peripheral sensory neuropathy, a transient rise in aminotransferases, myelosuppression, and gastrointestinal adverse events (table 2). Grade 3 or 4 neutropenia was observed in seven patients, including one with grade 3 neutropenic fever, and three patients had grade 3 thrombocytopenia (table 2). Grade 3 or 4 nonhaematological toxicities included anorexia (three patients), fatigue (three patients), and a transient rise in aminotransferases, with five patients experiencing a grade 3 rise in alanine aminotransferase and two with a grade 3 rise in aspartate aminotransferase. Gastrointestinal adverse events were mild, with grade 3 diarrhoea observed in one patient and nausea and vomiting in two patients. Peripheral neuropathy was generally mild, and five patients developed grade 3 neuropathy. Grade 3 and 4 bevacizumabrelated adverse events included grade 3 hypertension (five patients), grade 4 cardiac ischaemia (one patient), grade 3 proteinuria (one patient), and grade 3 (one patient) and grade 4 (one patient) thrombosis. No grade 3 or 4 bleeding events were observed. |
| Conclusions: | GEMOXB showed antitumour activity with tolerable safety in patients with advanced BTCs. Decreases in SUV(max) on [(18)F]FDGPET scans after treatment they were associated with disease control and increases in PFS and overall survival. |