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

This study has been terminated.
(The scientific commitee decided to stop the inclusions and exploit the results.)
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00327093
First received: May 17, 2006
Last updated: February 6, 2009
Last verified: February 2009

May 17, 2006
February 6, 2009
May 2006
October 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00327093 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Correlation between the response at 2 months and that at 6 months of treatment (taking in account the therapeutic adjustments during the 6-month follow-up).
Not Provided
Not Provided
 
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Neoplasm Metastasis
  • Drug: cetuximab
    indication : second intention treatment
    Other Name: Erbitux
  • Drug: bevacizumab
    Indication: first intention treatment
    Other Name: Avastin
  • Experimental: 1
    Bevacizumab
    Intervention: Drug: bevacizumab
  • Experimental: 2
    Cetuximab
    Intervention: Drug: cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
October 2008
October 2008   (final data collection date for primary outcome measure)

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:

  • 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00327093
2005-401
Not Provided
Jean-Alain CHAYVIALLE, Pr, Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Jean-Alain Chayvialle, MD Hospices Civils de Lyon
Hospices Civils de Lyon
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP