| General information |
| Database: | DB00714 |
| Objective: | Cediranib is a highly potent inhibitor of vascular endothelial growth factor (VEGF) signalling with activity against all three VEGF receptors. Bevacizumab is an antiVEGFA monoclonal antibody with clinical benefit in previously treated metastatic colorectal cancer (mCRC). |
| Authors: | Cunningham D, et al |
| Title: | Cediranib with mFOLFOX6 vs bevacizumab with mFOLFOX6 in previously treated metastatic colorectal cancer. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 23299530 |
| Trial Design |
| Clinical Trial Id: | NCT00278889 |
| Agent: | Cediranib bevacizumab
|
| Target: | NA
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Cediranib or bevacizumab+chemotherapy |
| Study Type: | randomised, doubleblind, phase II study |
| Key Patients Feature: | cted in adult patients withcarcinoma of the colon or rectum. patients were included if theyhad histologically or cytologically confirmed mCRC, with one ormore measurable lesions X10mm in the longest diameter by spiralcomputed tomography, or 20mm with conventional techniques, according to Response Evaluation Criteria In Solid Tumours(RECIST version 1.0). patients were also required to have receivedone prior systemic therapy for mCRC with documented progressionduring or following therapy, have a World Health Organisation(WHO) performance status of 0-2 and a life expectancy ofX12 weeks. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Cediranib with mFOLFOX6 vs bevacizumab with mFOLFOX6 |
| Treatment Info: | Patients with mCRC who had progressed following firstline therapy were randomised 1:1:1 to modified (m)FOLFOX6 plus cediranib (20 or 30 mg day(1)) or bevacizumab (10 mg kg(1) every 2 weeks). |
| Primary End Point: | progression free survival (PFS) between treatment arms. |
| Secondary End Point: | objective response rate (ORR), overall survival (OS), safety and tolerability, and healthrelated quality of life |
| Patients Number: | 210 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS in the cediranib 20 mg, cediranib 30 mg and bevacizumab groups was 5.8, 7.2 and 7.8 months, respectively. |
| Median OS A vs. C: | Median survival times were 14.3 months, 16.8 months and 19.6 months in the cediranib 20 mg, cediranib 30 mg and bevacizumab groups, respectively. |
| Adverse Event(agent arm): | Grade X3 adverse events were more common with cediranib 30 mg (91.8%) vs cediranib 20 mg (81.4%) or bevacizumab (84.8%). In all groups, the most common AEs were diarrhoea, fatigue, nausea and hypertension. |
| Conclusions: | There they were no statistically significant differences bettheyen treatment arms for PFS or OS. When combined with mFOLFOX6, the 20 mg day(1) dose of cediranib was better tolerated than the 30 mg day(1) dose. |