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Colorectal CancerAVECCNCT01405430

Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab

A study testing Bevacizumab + blood samples in people with Colorectal Cancer and Metastasis, run by Centre Leon Berard at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response. Biological factors will be correlated to clinical outcome measures. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Metastasis
What is being tested?
Bevacizumab + blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
2 sitesFrance
Study dates
May 2010to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line.
  • 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.

Who cannot join

  • Prior chemotherapy for the metastatic cancer.
  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • Centre Léon Bérard

    Lyon, 69373

Other trials in France

About this study

Official title: Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab

It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.

Biological factors will be correlated to clinical outcome measures.

Read more

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.

Being tested
Bevacizumab + blood samples
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab + blood samplesBiological

    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.

Study groups in NCT01405430
Study groupRoleWhat they receive
Bevacizumab + blood samplesExperimentalNot described
Receives: Biological: Bevacizumab + blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate to treatment

    A 30% response rate (complete or partial response) to treatment is expected. The response will be assessed according to RECIST criteria. This primary outcome measure is defined by the observation of at least one objective response during the treatment.

    This outcome measure will be correlated to biological factors.

    Measured: Up to 1 year at most

Secondary outcomes (5)

  1. Clinical benefit

    The clinical benefit is based on complete response, partial response or stable disease.

    This outcome measure will be correlated to biological factors.

    Measured: At progression or up to 1 year at most

  2. Evaluation of progression-free survival

    This outcome measure will be correlated to biological factors.

    Measured: From the beginning of treatment to progression, death or last available information

  3. Evaluation of overall survival

    This outcome measure will be correlated to biological factors.

    Measured: From the beginning of treatment to death or last available information

  4. Evaluation of tumoral markers

    Evaluation of ACE and Ca19-9

    Measured: At progression with bevacizumab or up to 1 year of follow-up at most

  5. Evaluation of vascular toxicities

    Assess the link between vascular toxicities and VE-cadherin rate. These toxicities will be assessed during the follow-up of patients.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2011 (estimated)
  2. Study startMay 2010
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01405430
Sponsor's protocol ID
AVECC
Other IDs
ET2010-003
Acronym
AVECC
Status last verified
Jun 2015
First submitted
26 Jul 2011
Last updated
29 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bouvier AM, Remontet L, Jougla E, Launoy G, Grosclaude P, Buemi A, Tretarre B, Velten M, Dancourt V, Menegoz F, Guizard AV, Mace Lesec'h J, Peng J, Bercelli P, Arveux P, Esteve J, Faivre J. Incidence of gastrointestinal cancers in France. Gastroenterol Clin Biol. 2004 Oct;28(10 Pt 1):877-81. doi: 10.1016/s0399-8320(04)95152-4.

    PubMed 15523225

  • 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.

    PubMed 15639298

  • Kozloff M, Yood MU, Berlin J, Flynn PJ, Kabbinavar FF, Purdie DM, Ashby MA, Dong W, Sugrue MM, Grothey A; Investigators of the BRiTE study. Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study. Oncologist. 2009 Sep;14(9):862-70. doi: 10.1634/theoncologist.2009-0071. Epub 2009 Sep 2.

    PubMed 19726453

  • Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

    PubMed 19339720

  • Gruenberger B, Tamandl D, Schueller J, Scheithauer W, Zielinski C, Herbst F, Gruenberger T. Bevacizumab, capecitabine, and oxaliplatin as neoadjuvant therapy for patients with potentially curable metastatic colorectal cancer. J Clin Oncol. 2008 Apr 10;26(11):1830-5. doi: 10.1200/JCO.2007.13.7679.

    PubMed 18398148

  • 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.

    PubMed 15867200

  • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

    PubMed 15175435

  • Kabbinavar FF, Schulz J, McCleod M, Patel T, Hamm JT, Hecht JR, Mass R, Perrou B, Nelson B, Novotny WF. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. J Clin Oncol. 2005 Jun 1;23(16):3697-705. doi: 10.1200/JCO.2005.05.112. Epub 2005 Feb 28.

    PubMed 15738537

  • 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.

    PubMed 18421054

  • 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.

    PubMed 19483739

  • 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.

    PubMed 16365183

  • 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.

    PubMed 19047116

  • 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.

    PubMed 18824714

  • Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. doi: 10.1038/nm988. Epub 2004 Jan 25.

    PubMed 14745444

  • 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.

    PubMed 12130501

Questions about this trial

What is this clinical trial studying?

A study testing Bevacizumab + blood samples in people with Colorectal Cancer and Metastasis, run by Centre Leon Berard at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate to treatment (time frame: Up to 1 year at most). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405430, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.

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