Entry Detail
| General information | |
| Database: | DB00729 |
| Objective: | The safety and tolerability of vandetanib (ZACTIMA; ZD6474) plus FOLFIRI was investigated in patients with advanced colorectal cancer (CRC). |
| Authors: | Saunders MP, et al |
| Title: | Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an openlabel, multicentrephase I study. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2009 |
| PMID: | 19184020 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | vandetanib |
| Target: | Epidermal growth factor receptor Vascular endothelial growth factor receptor 2 Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Vandetanib with FOLFIRI |
| Study Type: | analysis of results from a multicentre, openlabel, ascending dose, phase Istudy |
| Key Patients Feature: | Patient eligibility included histologically conWrmed metastatic colorectal adenocarcinoma (stage IV); suitability for Wrst or secondline chemotherapy; age 18 years; a WHOperformance status of 0 or 1; and adequate cardiac, haematopoietic, hepatic and renal function. Patients with brainmetastases were eligible if treated at least 4 weeks beforethe start of study treatment and if clinically stable withoutsteroid treatment for 1 week. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients eligible for first or secondline chemotherapy received oncedaily oral doses of vandetanib (100 or 300 mg) plus 14day treatment cycles of FOLFIRI. |
| Primary End Point: | Safety and tolerability; Pharmacokinetic assessments; Efficacy measurements |
| Secondary End Point: | NA |
| Patients Number: | 21 |
| Trial Results | |
| DLT_MTD: | There were no DLTs in the vandetanib 100 mg cohort andone DLT of hypertension (CTCAE grade 3) in the 300 mgcohort. The most common adverse events were diarrhoea(n = 20), nausea (n = 12) and fatigue (n = 10). |
| Objective Response Rate: | two conWrmed partial responses in the100 mg cohort and 9 patients with stable disease 8 weeks(100 mg, n = 7; 300mg, n = 2) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common adverse events were diarrhoea (n = 20), nausea (n = 12) and fatigue (n = 10). Two patients (one in each cohort) discontinued vandetanib dueto adverse events (rash, 100 mg cohort; hypertension, 300 mg cohort). |
| Conclusions: | Oncedaily vandetanib (100 or 300 mg) in combination with a standard FOLFIRI regimen was generally well tolerated in patients with advanced CRC. |