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Completed

NCT Number: NCT00489697

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU d'ANGERS, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

real-time contrast-enhanced ultrasound imaging (CEUS)

Device

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)

Primary outcomes

  1. functional vascular changes in tumour vascularity of hepatic metastases

    Time frame: 2 months

  2. Pharmacokinetic of bevacizumab between each cure of bevacizumab based chemotherapy

    Time frame: 2 months

  3. ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound

    Time frame: 2 months

  4. evaluation of the response to bevacizumab based chemotherapy by RECIST criteria

    Time frame: 2 months

Secondary outcomes

  1. bevacizumab-related toxicity

    Time frame: 2 months

  2. response duration

    Time frame: 2 years

  3. time to disease progression

    Time frame: 2 years

  4. survival time

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jun 21, 2007
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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