| General information |
| Database: | DB00120 |
| Objective: | to assess the efficacy and toxicity of cediranib in patients with hepatocellular carcinoma. |
| Authors: | Alberts SR, et al |
| Title: | Cediranib (AZD2171) in patients with advanced hepatocellular carcinoma: a phase II North Central Cancer Treatment Group Clinical Trial. |
| Journal: | Am J Clin Oncol. |
| Year: | 2012 |
| PMID: | 21422991 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cediranib
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II North Central Cancer Treatment Group (NCCTG) Clinical TrialI |
| Key Patients Feature: | histologic confirmation of locally advanced or metastatic hepatocellular carcinoma (BarcelonaClinic Liver Cancer Stage C)7 deemed unresectable, not amenable to local modalities of treatment, and not candidates for liver transplant |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received 45 mg of cediranib orally, once daily, for 28day cycles. |
| Primary End Point: | 6month survival. |
| Secondary End Point: | tumor response, time to progression, and toxicity. |
| Patients Number: | 28 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | No patients experienced confirmed response. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median time to progression was 2.8 months (95% confidence interval, 2.34.4 mo). |
| Median OS A vs. C: | 12 patients (42.9%) survived 6 months, 15 (53.6%) died within 6 months, and 1 (3.6%) was lost to followup before 6 months. The median overall survival was 5.8 months (95% confidence interval, 3.47.3 mo). |
| Adverse Event(agent arm): | Twentysix patients (93%) experienced a grade 3+ adverse event with the most common adverse event s being fatigue (46%), anorexia (25%), hypertension (21%), and elevated alanine aminotransferase (18%). |
| Conclusions: | Owing to the toxicity, cediranib at this dose and schedule is not an effective treatment in patients with unresectable or metastatic hepatocellular carcinoma. |