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

NCT00327093 | Terminated Phase 4

• 1 other identifier: 2005-401
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.The organisational objective is to develop a tumour bank of metastatic colorectal cancer.
3. 3.CT scan: RECIST criteria (gold standard);
4. 4.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).
5. 5.Descriptive analyses;
6. 6.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
7. 7.Analysis of prognostic factors:
8. 8.Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
9. 9.Multivariate analysis of prognostic factors;
10. 10.Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.

Conditions

Colorectal Cancer; Neoplasm Metastasis

Keywords

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

Outcome Measures

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

  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)

  at 6 month

Study Arms (2)

1

EXPERIMENTAL

Bevacizumab

Drug: bevacizumab

2

EXPERIMENTAL

Cetuximab

Drug: cetuximab

Interventions

cetuximab DRUG

indication : second intention treatment

Also known as: Erbitux

2

bevacizumab DRUG

Indication: first intention treatment

Also known as: Avastin

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Jean-Alain Chayvialle

Lyon, 69003, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Cetuximab; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jean-Alain Chayvialle, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: May 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 9, 2009

Record last verified: 2009-02

Locations

FR (1)