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Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. An Italian Trial

Phase 2
18 Years
80 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab. An Italian Trial

Pts meeting eligibility criteria will be registered, providing the availability of material
for molecular analysis. Tumour specimens and blood sample will be collected to perform
genomic, ICH and proteomic analyses in order to identify the molecular characteristics of

After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be

Access to registration system will be allowed via web.

Patients,KRAS wild-type receive:

- Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of
500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with
LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an
intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU
bolus injection on days 1 and 2

Inclusion Criteria

Inclusion criteria

- Signed written informed consent for biological analysis (all pts)

- Signed written informed consent for enrolment (pts with KRAS wild type)

- Male or female aged > or = 18 years

- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum

- KRAS evaluation availability with wild-type result

- Metastatic CRC not suitable for curative-intent resection

- Availability of tumour samples (or able and willing to provide tumour sample) and
blood for biological analysis

- Presence of at least one lesion measurable unidimensionally by computed tomography
(CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within
an irradiated area)

- Eastern cooperative oncology group-performance status (ECOG-PS) <2

Exclusion criteria

- Brain metastasis (known or suspected)

- Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the
chemotherapy treatment free interval is > 6 months

- Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol

- Any investigational agent(s) within 4 weeks prior to entry

- Previous exposure to HER-axis -pathway targeting therapy

- Leucocytes <3.0 x 109/L and neutrophils <1.5 x 109/L, platelets <100 x 109/L, and
hemoglobin <9 g/dL

- Bilirubin level either normal or >1.5 x ULN

- ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present)

- Serum creatinine >1.5 x ULN

- Clinically relevant coronary artery disease or a history of a myocardial infarction
within the last 12 months

- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

- Pre-existing neuropathy > grade 1

- Known grade 3 or 4 allergic reaction to any of the components of the treatment

- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ
of the cervix. (Pts with a previous malignancy but without evidence of disease for >
or equal 5 years will be allowed to enter the trial)

- Pregnancy or lactation

- Inadequate contraception (male or female pts) if of childbearing or procreational

- Known drug abuse/ alcohol abuse

- Legal incapacity or limited legal capacity

- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

untill 48 months

Safety Issue:


Principal Investigator

Roberto Labianca, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ospedali Riuniti di Bergamo


Italy: The Italian Medicines Agency

Study ID:




Start Date:

April 2009

Completion Date:

July 2013

Related Keywords:

  • Colorectal Cancer
  • Metastatic CRC
  • Wild-type KRAS
  • Patients with histologically documented metastatic wild- type KRAS CRC not suitable
  • for curative-intent resection
  • Colorectal Neoplasms