Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab
NCT ID: NCT01405430
Last Updated: 2015-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2010-05-31
2014-05-31
Brief Summary
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Biological factors will be correlated to clinical outcome measures.
100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.
Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Bevacizumab + blood samples
Bevacizumab + blood samples
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
Interventions
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Bevacizumab + blood samples
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
Eligibility Criteria
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Inclusion Criteria
* At least one extra-osseous, non-irradiated, measurable site (\>= 10 mm with spiral CT).
* No prior radiotherapy treatment unless treatment is over for at least 4 weeks.
* Adult patients.
* PS \<= 2.
* Life expectancy greater than 3 months.
* Mandatory affiliation with a healthy security insurance.
* Signed written informed consent.
Exclusion Criteria
* Prior bevacizumab treatment.
* Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease.
* Patient deprived of freedom.
* Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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UMR-S Inserm 1036
UNKNOWN
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Christelle DE LA FOUCHARDIERE, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Hôpital Privé Jean Mermoz
Lyon, , France
Centre Léon Bérard
Lyon, , France
Countries
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References
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Weitz J, Koch M, Debus J, Hohler T, Galle PR, Buchler MW. Colorectal cancer. Lancet. 2005 Jan 8-14;365(9454):153-65. doi: 10.1016/S0140-6736(05)17706-X.
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Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. doi: 10.1200/JCO.2005.00.232. Epub 2005 May 2.
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Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930.
Jain RK, Duda DG, Willett CG, Sahani DV, Zhu AX, Loeffler JS, Batchelor TT, Sorensen AG. Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol. 2009 Jun;6(6):327-38. doi: 10.1038/nrclinonc.2009.63.
Jubb AM, Hurwitz HI, Bai W, Holmgren EB, Tobin P, Guerrero AS, Kabbinavar F, Holden SN, Novotny WF, Frantz GD, Hillan KJ, Koeppen H. Impact of vascular endothelial growth factor-A expression, thrombospondin-2 expression, and microvessel density on the treatment effect of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2006 Jan 10;24(2):217-27. doi: 10.1200/JCO.2005.01.5388. Epub 2005 Dec 19.
Burstein HJ, Chen YH, Parker LM, Savoie J, Younger J, Kuter I, Ryan PD, Garber JE, Chen H, Campos SM, Shulman LN, Harris LN, Gelman R, Winer EP. VEGF as a marker for outcome among advanced breast cancer patients receiving anti-VEGF therapy with bevacizumab and vinorelbine chemotherapy. Clin Cancer Res. 2008 Dec 1;14(23):7871-7. doi: 10.1158/1078-0432.CCR-08-0593.
Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612.
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Corada M, Zanetta L, Orsenigo F, Breviario F, Lampugnani MG, Bernasconi S, Liao F, Hicklin DJ, Bohlen P, Dejana E. A monoclonal antibody to vascular endothelial-cadherin inhibits tumor angiogenesis without side effects on endothelial permeability. Blood. 2002 Aug 1;100(3):905-11. doi: 10.1182/blood.v100.3.905.
Gory-Faure S, Prandini MH, Pointu H, Roullot V, Pignot-Paintrand I, Vernet M, Huber P. Role of vascular endothelial-cadherin in vascular morphogenesis. Development. 1999 May;126(10):2093-102. doi: 10.1242/dev.126.10.2093.
Wallez Y, Vilgrain I, Huber P. Angiogenesis: the VE-cadherin switch. Trends Cardiovasc Med. 2006 Feb;16(2):55-9. doi: 10.1016/j.tcm.2005.11.008.
Wallez Y, Cand F, Cruzalegui F, Wernstedt C, Souchelnytskyi S, Vilgrain I, Huber P. Src kinase phosphorylates vascular endothelial-cadherin in response to vascular endothelial growth factor: identification of tyrosine 685 as the unique target site. Oncogene. 2007 Feb 15;26(7):1067-77. doi: 10.1038/sj.onc.1209855. Epub 2006 Aug 14.
Other Identifiers
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ET2010-003
Identifier Type: OTHER
Identifier Source: secondary_id
AVECC
Identifier Type: -
Identifier Source: org_study_id
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