Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Biomarker/Laboratory analysis, Diagnostic, Tissue collection/Repository, Treatment Active 18 to 75 Other 2005-401 NCT00327093

Trial Description

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Centre Hospitalier Lyon Sud

Jean-Alain Chayvialle, MD

Principal Investigator

Jean-Alain Chayvialle, MD		Ph: 33 4.72.11.01.44
		Email: jean-alain.chayvialle@chu-lyon.fr

France
	Lyon
	Jean-Alain Chayvialle
		Jean-Alain Chayvialle, MD	Ph: 33 4.72.11.01.44
			Email: jean-alain.chayvialle@chu-lyon.fr
		Jean-Alain Chayvialle, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00327093
Information obtained from ClinicalTrials.gov on July 16, 2008