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A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.

Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.

Inclusion Criteria

Inclusion Criteria

- Signed written informed consent

- Inpatient or outpatient ≥ 18 years of age

- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum

- First occurrence of metastatic disease (not curatively resectable)

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

- Life expectancy of ≥ 3 months

- Karnofsky performance status of ≥ 60, at study entry

- White blood cell count (WBC) ≥ 3 x 10^9/L, with neutrophils ≥ 1.5 x 10^9/L, platelets
≥ 100 x 10^9/L, and hemoglobin ≥ 9 g/dL

- Aspartate transaminase and alanine transaminase ≤ 2.5 x Upper Limit of Normal (ULN)
(≤ 5 x ULN if liver metastasis are present)

- Normal serum creatinine (in case of elevated creatinine, labelled
ethylenediaminetetraacetic acid clearance ≥ 65 mL/min is acceptable)

- Effective contraception for both male and female subjects if the risk of conception

- Tumor biopsy or archived sample available

Exclusion criteria:

- Brain metastasis and/or leptomeningeal disease (known or suspected)

- Previous chemotherapy for colorectal cancer except adjuvant treatment with
progression of disease documented > 6 months after end of adjuvant treatment.

- Previous oxaliplatin-based chemotherapy

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

- Concurrent or previous chronic systemic immune therapy, targeted therapy,
anti-vascular epithelial growth factor (VEGF) therapy, epidermal growth factor
receptor (EGFR) pathway targeting therapy not indicated in the study protocol

- Concurrent hormonal therapy not indicated in the study protocol except for
physiologic replacement or contraception

- Clinically relevant coronary artery disease, history of myocardial infarction in the
last 12 months, or high risk of uncontrolled arrhythmia

- Peripheral neuropathy >grade 1

- Known hypersensitivity reaction to any of the components of the treatment.

- Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive
cancer of the cervix. (Subjects with a previous malignancy but without evidence of
disease for ≥ 5 years will be allowed to enter the study)

- Pregnancy (absence to be confirmed by ß-human chorionic gonadotrophin test) or
lactation period

- 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 subject to complete the study or sign meaningful informed consent

- Participation in another clinical study within the 30 days before randomization

- Significant disease which, in the investigator's opinion, would exclude the subject
from the study

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria

Outcome Time Frame:

Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009

Safety Issue:


Principal Investigator

Jean-Yves Douillard, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre R Gauducheau


Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Study ID:




Start Date:

December 2006

Completion Date:

March 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Cancer
  • Colorectal
  • Metastatic
  • Colorectal Neoplasms