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TerminatedNCT00327093Updated Feb 9, 2009

Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

A Phase 4 interventional study of cetuximab and bevacizumab in Colorectal Cancer and Neoplasm Metastasis, sponsored by Hospices Civils de Lyon. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-02-09.

Sponsored by Hospices Civils de Lyon · Phase 4, Interventional, and Treatment

Why this study was terminated
The scientific commitee decided to stop the inclusions and exploit the results.
Phase
Phase 4
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria).

Secondary Objectives:

  1. This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment.
  2. The organisational objective is to develop a tumour bank of metastatic colorectal cancer.

Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.

Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used.

Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.

Studied Factors:

Radiology:

  1. CT scan: RECIST criteria (gold standard);
  2. Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).

Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])

Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms

Statistics:

  1. Descriptive analyses;
  2. Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months

  3. Analysis of prognostic factors:

    1. Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
    2. Multivariate analysis of prognostic factors;
    3. Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.
02

Conditions studied

  • Colorectal Cancer
  • Neoplasm Metastasis

Keywords

  • Colorectal cancer,
  • immunohistochemistry,
  • monoclonal antibodies,
  • predictive model,
  • antiangiogenic agents,
  • medical imaging
  • Colorectal cancer with liver metastases
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 31 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.

Browse Hospices Civils de Lyon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients >= 18 years old
  • Patients with colon or rectal carcinoma histologically proven
  • Patients with metastases (synchronous or metachronous)
  • Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
  • Performance status (World Health Organization [WHO]) = 0, 1, or 2
  • Life expectancy >= 3 months
  • Patients with normal haematological, kidney, and liver parameters (PNN > 1.5 x 10\^9/L, platelets > 100 10\^9/L, total bilirubin \<= 1.25 x upper limit of normal (ULN), ASAT/ALAT \<= 5 x ULN, creatinaemia \<= 135 µmol/L (1.5 mg/dL)
  • No cardiac or coronary insufficiency untreated
  • At least 4 weeks between surgery and study beginning
  • Patients can have a biopsy of the hepatic lesion identified by ultrasound.
  • Informed consent signed.

Exclusion criteria

Exclusion Criteria:

  • Patients with symptomatic tumors (colon or rectal)
  • Patients with others tumors not cured
  • Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.
  • Patients who participated in another clinical trial since less than 30 days
  • Pregnancy or breast-feeding women
  • Patients who cannot be treated because of active infection or other serious disease.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    1

    Bevacizumab

    Drug: bevacizumab

  • Experimental
    2

    Cetuximab

    Drug: cetuximab

Interventions

  • Drugcetuximab

    indication : second intention treatment

    Also known as: Erbitux

  • Drugbevacizumab

    Indication: first intention treatment

    Also known as: Avastin

06

What researchers measure

Primary outcomes

  1. Elaboration of a predictive model, based on biological and functional imaging parameters, for the response to monoclonal antibodies as assessed through RECIST criteria 2 months after the beginning of treatment

    Time frame: at 7 weeks

Secondary outcomes

  1. Correlation between the response at 2 months and that at 6 months of treatment (taking into account the therapeutic adjustments during the 6-month follow-up)

    Time frame: at 6 month

07

Study locations

1 site
  • Jean-Alain Chayvialle
    Lyon, 69003, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2006, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2006
First posted
May 18, 2006
Start
May 2006
Primary completionActual
Oct 2008
CompletionActual
Oct 2008
Last update
Feb 9, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00327093
Lead sponsor
Hospices Civils de Lyon
First posted
May 18, 2006
Start date
May 2006
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Feb 9, 2009

Study contacts

Jean-Alain Chayvialle, MD
principal investigator · Hospices Civils de Lyon
View the source record on ClinicalTrials.gov ↗

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