PMID- 21540865
OWN - NLM
STAT- MEDLINE
DCOM- 20110721
LR  - 20211020
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Print)
IS  - 0007-0920 (Linking)
VI  - 104
IP  - 11
DP  - 2011 May 24
TI  - Phase I/II trial of cilengitide with cetuximab, cisplatin and 5-fluorouracil in 
      recurrent and/or metastatic squamous cell cancer of the head and neck: findings 
      of the phase I part.
PG  - 1691-6
LID - 10.1038/bjc.2011.152 [doi]
AB  - BACKGROUND: Novel therapies are needed to improve the poor prognosis of patients 
      with recurrent and/or metastatic squamous cell cancer of the head and neck 
      (SCCHN). METHODS: ADVANTAGE is a phase I/II, multicentre study evaluating the 
      integrin inhibitor cilengitide combined with cetuximab and platinum-based 
      chemotherapy in patients with recurrent and/or metastatic SCCHN. The phase I part 
      tested cilengitide (500, 1000 and 2000 mg) twice weekly with standard doses of 
      cetuximab, cisplatin and 5-fluorouracil. RESULTS: Ten patients (9 male, 1 female; 
      median 56 years old) were included in the phase I part. No dose-limiting 
      toxicities (DLTs: grade 3/4 toxicities in the first 3 weeks as defined per 
      protocol) or deaths occurred. The most common adverse events (AEs) were 
      constipation, rash, nausea, anorexia and fatigue. Cilengitide-related grade 3/4 
      AEs, all of which occurred after the DLT observation period, were anaemia, 
      angioedema, asthenia, mucosal inflammation, nausea and vomiting (one event per 
      category). Best overall tumour response was partial response (PR) for 4 out of 10 
      patients and stable disease (SD) for 6 out of 10 patients across all cohorts. 
      Disease control rate (complete response, PR and SD) was 100%. CONCLUSION: 
      Cilengitide combined with cetuximab and platinum-based chemotherapy was well 
      tolerated. No DLTs or unexpected AEs were observed. Cilengitide 2000 mg was 
      considered safe and was selected for the subsequent randomised phase II part 
      assessing progression-free survival.
FAU - Vermorken, J B
AU  - Vermorken JB
AD  - Department of Medical Oncology, Antwerp University Hospital, Wilrijkstraat 10, 
      Edegem 2650, Belgium. Jan.B.Vermorken@uza.be
FAU - Guigay, J
AU  - Guigay J
FAU - Mesia, R
AU  - Mesia R
FAU - Trigo, J M
AU  - Trigo JM
FAU - Keilholz, U
AU  - Keilholz U
FAU - Kerber, A
AU  - Kerber A
FAU - Bethe, U
AU  - Bethe U
FAU - Picard, M
AU  - Picard M
FAU - Brummendorf, T H
AU  - Brummendorf TH
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110503
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - PQX0D8J21J (Cetuximab)
RN  - Q20Q21Q62J (Cisplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carcinoma/drug therapy/pathology
MH  - Carcinoma, Squamous Cell
MH  - Cetuximab
MH  - Cisplatin/administration & dosage
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Head and Neck Neoplasms/drug therapy/pathology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis/drug therapy
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Neoplasms, Squamous Cell/drug therapy/pathology
MH  - Squamous Cell Carcinoma of Head and Neck
PMC - PMC3111165
EDAT- 2011/05/05 06:00
MHDA- 2011/07/22 06:00
PMCR- 2012/05/24
CRDT- 2011/05/05 06:00
PHST- 2011/05/05 06:00 [entrez]
PHST- 2011/05/05 06:00 [pubmed]
PHST- 2011/07/22 06:00 [medline]
PHST- 2012/05/24 00:00 [pmc-release]
AID - bjc2011152 [pii]
AID - 10.1038/bjc.2011.152 [doi]
PST - ppublish
SO  - Br J Cancer. 2011 May 24;104(11):1691-6. doi: 10.1038/bjc.2011.152. Epub 2011 May 
      3.