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Open-label, Phase II, Randomised, Pilot Study to Evaluate the Safety and Efficacy of Combination Therapy With Cetuximab and FOLFOX4 or FOLFOX4 Alone in Patients Colorectal Cancer and Initially Non-resectable

Phase 2
18 Years
75 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Open-label, Phase II, Randomised, Pilot Study to Evaluate the Safety and Efficacy of Combination Therapy With Cetuximab and FOLFOX4 or FOLFOX4 Alone in Patients Colorectal Cancer and Initially Non-resectable

Inclusion Criteria:

- Written informed consent.

- Men and women < 75 years

- Histologically confirmed diagnosis of CRC

- Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due
to fulfillment of one of the following criteria:

1. Number of hepatic metastases > or= 4;

2. Size of one or more hepatic metastases > 5 cm diameter;

3. Vascular involvement and/or poor site that prevent complete resection of hepatic
disease and/or require resection with the remaining liver mass less than 25-30%
of functional liver.

- Presence of at least one lesion detectable by two-dimensional measurement.

- Karnofsky functional status >or=70% at the time of enrollment in study

- Life expectancy greater than 3 months.

- Patients must not have received chemotherapy for advanced/metastatic disease.

- Patients with the following characteristics will be enrolled:

1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or
capecitabine +/- radiotherapy with disease-free period > 6 months following
conclusion of treatment.

2. Recurrence after surgical and/or radiotherapy treatment without adjuvant
systemic treatment.

3. De novo diagnosis of disease.

- Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine
aminotransferase (ALT/SGPT) < or = 2.5 x ULN (< or = 5 x ULN if there are hepatic
metastases) and total bilirubin count < 1.5 x ULN.

- Proper kidney function, defined as serum creatinine < 1.5 x ULN.

- Proper hematological function, defined as neutrophil count > or = 1.5 x 109/l ,
platelets > or = 100 X 109/l and hemoglobin > or = 9 g/dl.

- Effective birth control method for men as well as women if there is possibility of

Exclusion Criteria:

- Documented or suspected cerebral and/or leptomeningeal metastases.

- Metastasis in any other non-hepatic site, including extrahepatic lymph node

- Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to
enrollment in the study.

- Participation in another clinical trial with medication in the past 30 days.

- Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone
therapy or any other investigational drug.

- Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma
or pre-invasive cervical carcinoma.

- Any investigational drug during the 4 weeks prior to enrolment.

- Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or
EGFR-targeted treatment.

- Prior participation in study in which treatment with cetuximab can be assigned
(whether or not treatment with cetuximab is received)

- Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.

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

- Clinically relevant peripheral neuropathy.

- Clinically relevant myocardial disease or history of myocardial infarction in the
past 12 months.

- Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.

- Any medical or psychological disorder which, in the opinion of the investigator, does
not allow the patient to conclude the study or sign the informed consent.

- Pregnant or nursing woman

Type of Study:


Study Design:

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

Outcome Measure:

Determine confirmed objective response rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Albert Abad

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

February 2005

Completion Date:

February 2009

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • cetuximab
  • Colorectal Neoplasms