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Evaluation of Contrast-Enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by University Hospital, Tours.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00489697
First received: June 20, 2007
Last updated: February 19, 2009
Last verified: February 2009
  Purpose
Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.

Condition Intervention
Metastatic Colorectal Cancer
Device: real-time contrast-enhanced ultrasound imaging (CEUS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Medical and Economical Evaluation of Contrast-Enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • functional vascular changes in tumour vascularity of hepatic metastases [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic of bevacizumab between each cure of bevacizumab based chemotherapy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • evaluation of the response to bevacizumab based chemotherapy by RECIST criteria [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bevacizumab-related toxicity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • response duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • time to disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • survival time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 (single arm)
patient with histologically confirmed colorectal tumor treated in first line by a bevacizumab based chemotherapy
Device: real-time contrast-enhanced ultrasound imaging (CEUS)
Real time contrast enhanced sonography was performed using an ultrasound dedicated system after bolus injection of 1.2 and 2x2.4 ml Sonovue ® (Bracco, Milan, Italy)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed colorectal tumor
  • first line treatment by a bevacizumab based chemotherapy
  • Target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and CT or MRI
  • Life expectancy > 2 months
  • OMS status =< 2
  • Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0
  • informed consent signed

Exclusion Criteria:

  • no target hepatic lesion detected by conventional ultrasonography
  • Prior bevacizumab treatment
  • Prior chemotherapy treatment for advanced disease
  • Clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration
  • Blood pressure >= 180/110 mmHg
  • Daily and chronic treatment by aspirin or AINS
  • Anticipation of need for major surgical procedure within 7 days prior day 0
  • Urine protein > 1g/24 Hours
  • Any contraindication in enhancing bevacizumab treatment
  • Serious, uncontrolled, concurrent infection(s) or illness(es)
  • pregnant and lactating woman
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489697

Locations
France
CHRU d'ANGERS
Angers, France, 49033
CRLCC, Centre Paul Papin
Angers, France, 49033
CHRU Besancon
Besançon, France, 25000
Hôpital Saint-André, CHRU Bordeaux
Bordeaux, France, 33075
CRLCC, Centre René Gauducheau
Nantes St Herblain, France, 44805
Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris
Paris, France, 75651
Hôpital Haut-Lévêque
Pessac, France, 33604
Hôpital La Milétrie, CHRU Poitiers
Poitiers, France, 86000
Hôpital Robert Debré, CHRU Reims
Reims, France, 51092
CHU Pontchaillou
Rennes, France, 35033
CRLCC, Centre Eugène Marquis
Rennes, France, 35042
Chru Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: François TRANQUART, Professor Centre Hospitalier de Tours, France
Principal Investigator: Thierry LECOMTE, Doctor Centre Hospitalier de Tours, France
Study Chair: Bruno GIRAUDEAU, Doctor INSERM CIC 2002, Centre Hospitalier de Tours, France
Study Chair: Emmanuel RUSCH, Professor Centre Hospitalier de Tours, France
  More Information

Publications:

Responsible Party: Directrice de la Recherche et des Affaires Médicales, University Hospital Tours
ClinicalTrials.gov Identifier: NCT00489697     History of Changes
Other Study ID Numbers: INCA06-FT/STIC-AVASTIN 
Study First Received: June 20, 2007
Last Updated: February 19, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
colorectal cancer
hepatic metastases
bevacizumab
anti-angiogenic agent
chemotherapy regimens
tumor vascularity
Contrast-enhanced ultrasound

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 02, 2016