PURPOSE: The safety and tolerability of vandetanib (ZACTIMA; ZD6474) plus FOLFIRI was investigated in patients with advanced colorectal cancer (CRC). METHODS: Patients eligible for first- or second-line chemotherapy received once-daily oral doses of vandetanib (100 or 300 mg) plus 14-day treatment cycles of FOLFIRI. RESULTS: A total of 21 patients received vandetanib 100 mg (n = 11) or 300 mg (n = 10) + FOLFIRI. Combination therapy was well tolerated at both vandetanib dose levels. There were no DLTs in the vandetanib 100 mg cohort and one DLT of hypertension (CTCAE grade 3) in the 300 mg cohort. The most common adverse events were diarrhoea (n = 20), nausea (n = 12) and fatigue (n = 10). Two patients (one in each cohort) discontinued vandetanib due to adverse events (rash, 100 mg cohort; hypertension, 300 mg cohort). There was no apparent pharmacokinetic interaction between vandetanib and FOLFIRI. Preliminary efficacy results included two confirmed partial responses in the 100 mg cohort and 9 patients with stable disease > or =8 weeks (100 mg, n = 7; 300 mg, n = 2). CONCLUSIONS: Once-daily vandetanib (100 or 300 mg) in combination with a standard FOLFIRI regimen was generally well tolerated in patients with advanced CRC.
PURPOSE: The safety and tolerability of vandetanib (ZACTIMA; ZD6474) plus FOLFIRI was investigated in patients with advanced colorectal cancer (CRC). METHODS: Patients eligible for first- or second-line chemotherapy received once-daily oral doses of vandetanib (100 or 300 mg) plus 14-day treatment cycles of FOLFIRI. RESULTS: A total of 21 patients received vandetanib 100 mg (n = 11) or 300 mg (n = 10) + FOLFIRI. Combination therapy was well tolerated at both vandetanib dose levels. There were no DLTs in the vandetanib 100 mg cohort and one DLT of hypertension (CTCAE grade 3) in the 300 mg cohort. The most common adverse events were diarrhoea (n = 20), nausea (n = 12) and fatigue (n = 10). Two patients (one in each cohort) discontinued vandetanib due to adverse events (rash, 100 mg cohort; hypertension, 300 mg cohort). There was no apparent pharmacokinetic interaction between vandetanib and FOLFIRI. Preliminary efficacy results included two confirmed partial responses in the 100 mg cohort and 9 patients with stable disease > or =8 weeks (100 mg, n = 7; 300 mg, n = 2). CONCLUSIONS: Once-daily vandetanib (100 or 300 mg) in combination with a standard FOLFIRI regimen was generally well tolerated in patients with advanced CRC.
Authors: Elizabeth R Kessler; S Gail Eckhardt; Todd M Pitts; Erica L Bradshaw-Pierce; Cindy L O'byrant; Wells A Messersmith; Sujatha Nallapreddy; Colin Weekes; Jennifer Spratlin; Christopher H Lieu; Madeleine A Kane; Sarah Eppers; Elizabeth Freas; Stephen Leong Journal: Invest New Drugs Date: 2015-12-30 Impact factor: 3.850
Authors: Philipp Harter; Jalid Sehouli; Rainer Kimmig; Jörn Rau; Felix Hilpert; Christian Kurzeder; Gabriele Elser; Andreas du Bois Journal: Invest New Drugs Date: 2013-09-05 Impact factor: 3.850
Authors: Vasiliki A Papadimitrakopoulou; Steven J Frank; Ezra W Cohen; Fred R Hirsch; Jeffrey N Myers; John V Heymach; Heather Lin; Hai T Tran; Changhu R Chen; Antonio Jimeno; Lucien Nedzi; Joseph R Vasselli; Elizabeth S Lowe; David Raben Journal: Head Neck Date: 2015-06-16 Impact factor: 3.147
Authors: Erica L Bradshaw-Pierce; Todd M Pitts; Gillian Kulikowski; Heather Selby; Andrea L Merz; Daniel L Gustafson; Natalie J Serkova; S Gail Eckhardt; Colin D Weekes Journal: PLoS One Date: 2013-03-08 Impact factor: 3.240