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


Phase 4
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer, Neoplasm Metastasis

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

at 7 weeks

Safety Issue:

No

Principal Investigator

Jean-Alain Chayvialle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2005-401

NCT ID:

NCT00327093

Start Date:

May 2006

Completion Date:

October 2008

Related Keywords:

  • Colorectal Cancer
  • Neoplasm Metastasis
  • Colorectal cancer,
  • immunohistochemistry,
  • monoclonal antibodies,
  • predictive model,
  • antiangiogenic agents,
  • medical imaging
  • Colorectal cancer with liver metastases
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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