PMID- 22904239
OWN - NLM
STAT- MEDLINE
DCOM- 20130620
LR  - 20201219
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 24
IP  - 1
DP  - 2013 Jan
TI  - Phase Ib safety and pharmacokinetic study of volociximab, an anti-alpha5beta1 integrin 
      antibody, in combination with carboplatin and paclitaxel in advanced 
      non-small-cell lung cancer.
PG  - 90-6
LID - 10.1093/annonc/mds281 [doi]
AB  - BACKGROUND: This phase Ib study evaluated volociximab, an anti-alpha5beta1 integrin 
      antibody, in combination with carboplatin (Eli Lilly and Co., Indianapolis, IN) 
      and paclitaxel (Taxol) in advanced, untreated non-small-cell lung cancer (NSCLC). 
      PATIENTS AND METHODS: Three cohorts were treated with volociximab (10, 20, or 30 
      mg/kg) for up to six 3-week cycles in combination with carboplatin-paclitaxel 
      chemotherapy and continued as maintenance therapy for patients with stable 
      disease (SD) or better. Dose-limiting toxic effects, adverse events (AEs), 
      pharmacokinetics, and anti-volociximab antibodies were assessed. RESULTS: A 
      maximum tolerated dose was not reached up to the maximum planned dose of 30 
      mg/kg. In 29 patients who received volociximab, the most common grade>/=3 AEs were 
      neutropenia (24%), hyponatremia (17%), and fatigue (10%). Three patients 
      experienced volociximab-related serious AEs. No hemorrhages were observed. Of 33 
      patients enrolled, 8 (24%) achieved a partial response and 17 (52%) had SD. The 
      median progression-free survival was 6.3 months (95% confidence interval 
      5.5-8.1). Levels of potential biomarkers of angiogenesis or metastasis were 
      reduced following six cycles of treatment. CONCLUSIONS: Volociximab combined with 
      carboplatin and paclitaxel was generally well-tolerated and showed preliminary 
      evidence of efficacy in advanced NSCLC.
FAU - Besse, B
AU  - Besse B
AD  - Cancer Medicine/Thoracic Unit, Institut Gustave Roussy, Villejuif, France.
FAU - Tsao, L C
AU  - Tsao LC
FAU - Chao, D T
AU  - Chao DT
FAU - Fang, Y
AU  - Fang Y
FAU - Soria, J-C
AU  - Soria JC
FAU - Almokadem, S
AU  - Almokadem S
FAU - Belani, C P
AU  - Belani CP
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120816
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Integrin alpha5beta1)
RN  - 496K5Z02NW (volociximab)
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects/pharmacokinetics
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage
MH  - Carboplatin/administration & dosage
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Cohort Studies
MH  - Humans
MH  - Integrin alpha5beta1/*immunology
MH  - Lung Neoplasms/*drug therapy
MH  - Maximum Tolerated Dose
MH  - Paclitaxel/administration & dosage
EDAT- 2012/08/21 06:00
MHDA- 2013/06/21 06:00
CRDT- 2012/08/21 06:00
PHST- 2012/08/21 06:00 [entrez]
PHST- 2012/08/21 06:00 [pubmed]
PHST- 2013/06/21 06:00 [medline]
AID - S0923-7534(19)37050-4 [pii]
AID - 10.1093/annonc/mds281 [doi]
PST - ppublish
SO  - Ann Oncol. 2013 Jan;24(1):90-6. doi: 10.1093/annonc/mds281. Epub 2012 Aug 16.