Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
History of Changes
  Purpose

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.

Condition Intervention Phase
Colorectal Cancer
Neoplasm Metastasis
 Drug: cetuximab
Drug: bevacizumab
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 31
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bevacizumab
 Drug: bevacizumab
Indication: first intention treatment
Other Name: Avastin
Experimental: 2
Cetuximab
 Drug: cetuximab
indication : second intention treatment
Other Name: Erbitux

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00327093

Locations
France
Jean-Alain Chayvialle
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Jean-Alain Chayvialle, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Jean-Alain CHAYVIALLE, Pr, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00327093     History of Changes
Other Study ID Numbers: 2005-401
Study First Received: May 17, 2006
Last Updated: February 6, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Colorectal cancer,
immunohistochemistry,
monoclonal antibodies,
predictive model,
 antiangiogenic agents,
medical imaging
Colorectal cancer with liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
 Rectal Diseases
Antibodies, Monoclonal
Bevacizumab
Cetuximab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015