Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study.

2.50
Hdl Handle:
http://hdl.handle.net/10541/53953
Title:
Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study.
Authors:
Saunders, Mark P; Wilson, R; Peeters, M; Smith, R; Godwood, A; Oliver, S; Van Cutsem, E
Abstract:
PURPOSE: The safety and tolerability of vandetanib (ZACTIMAtrade mark; 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 >/=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.
Affiliation:
Christie Hospital, Wilmslow Road, Manchester, M20 4BX, UK, Mark.Saunders@christie.nhs.uk.
Citation:
Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. 2009: Cancer Chemother. Pharmacol.
Journal:
Cancer Chemotherapy and Pharmacology
Issue Date:
29-Jan-2009
URI:
http://hdl.handle.net/10541/53953
DOI:
10.1007/s00280-008-0914-4
PubMed ID:
19184020
Type:
Article
Language:
en
ISSN:
1432-0843
Appears in Collections:
All Christie Publications ; Clinical Oncology

Full metadata record

DC FieldValue Language
dc.contributor.authorSaunders, Mark P-
dc.contributor.authorWilson, R-
dc.contributor.authorPeeters, M-
dc.contributor.authorSmith, R-
dc.contributor.authorGodwood, A-
dc.contributor.authorOliver, S-
dc.contributor.authorVan Cutsem, E-
dc.date.accessioned2009-03-11T09:31:10Z-
dc.date.available2009-03-11T09:31:10Z-
dc.date.issued2009-01-29-
dc.identifier.citationVandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. 2009: Cancer Chemother. Pharmacol.en
dc.identifier.issn1432-0843-
dc.identifier.pmid19184020-
dc.identifier.doi10.1007/s00280-008-0914-4-
dc.identifier.urihttp://hdl.handle.net/10541/53953-
dc.description.abstractPURPOSE: The safety and tolerability of vandetanib (ZACTIMAtrade mark; 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 >/=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.en
dc.languageENG-
dc.language.isoenen
dc.subjectVandetaniben
dc.subjectFOLFIRIen
dc.subjectColorectal Canceren
dc.subjectColorectal Adenocarcinomaen
dc.titleVandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study.en
dc.typeArticleen
dc.contributor.departmentChristie Hospital, Wilmslow Road, Manchester, M20 4BX, UK, Mark.Saunders@christie.nhs.uk.en
dc.identifier.journalCancer Chemotherapy and Pharmacologyen

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