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An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With KRAS Wild-type Status

Phase 3
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With KRAS Wild-type Status

Inclusion Criteria:

- Signed written informed consent (first and second)

- Chinese with Chinese citizenship

- Male or female subjects ≥18 years of age

- Medically accepted effective contraception if procreative potential exists
(applicable for both male and female subjects until at least 90 days after the last
dose of trial treatment)

- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum

- First occurrence of metastatic disease (not curatively resectable) KRAS wild-type
status in tumor tissue

- At least one measurable lesion by computer tomography (CT) or magnetic resonance
imaging (MRI) according to RECIST (not in an irradiated area)

- Life expectancy of at least 12 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry

- White blood cell count ≥ 3 × 10x9/L with neutrophils ≥ 1.5 × 10x9/L, platelet count ≥
100 × 10x9/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL)

- Total bilirubin ≤ 1.5 × upper limit of reference range

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of
reference range or ≤ 5 × upper reference range in subjects with liver metastasis

- Serum creatinine ≤ 1.5 × upper limit of reference range

- Recovery from relevant toxicity due to previous treatment before trial entry

Exclusion Criteria:

- Previous chemotherapy for CRC except adjuvant treatment if terminated > 9 months
(oxaliplatin-based chemotherapy) or > 6 months (non-oxaliplatin-based chemotherapy)
before the start of treatment in this trial

- Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before
trial treatment

- Previous treatment with monoclonal antibody therapy, vascular endothelial growth
factor (VEGF) pathway-targeting therapy, epidermal growth factor receptor (EGFR)
pathway-targeting therapy, or other signal transduction inhibitors

- History of organ allograft, autologous stem cell transplantation, or allogeneic stem
cell transplantation

- Renal replacement therapy

- Intake of any investigational medication within 30 days before trial entry

- Concurrent chronic systemic immune therapy or hormone therapy except physiologic

- Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony
stimulating factor (GM-CSF) within 3 weeks of trial entry (these growth factors may
be used during the trial thereafter)

- Other non-permitted concomitant anticancer therapies

- Known brain metastasis and/or leptomeningeal disease. Subjects with neurological
symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis

- Previous malignancy other than CRC in the last 5 years except basal cell cancer of
the skin or preinvasive cancer of the cervix

- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart
Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy,
uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial
infarction in the last 5 years, or left ventricular ejection fraction below the
institutional range of normal on a baseline multiple gated acquisition scan or

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

- Active clinically serious infections (> grade 2 National Cancer Institute-Common
Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active

- Known and declared history of human immunodeficiency virus (HIV) infection or chronic
hepatitis B or C

- Peripheral neuropathy > grade 1

- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
members who suffer(ed) from such

- Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder,
interstitial pneumonia, or liver failure

- Known hypersensitivity or allergic reactions against any of the components of the
trial treatments

- Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or

- Ongoing alcohol or drug abuse

- Presence of a medical or psychological condition that would not permit the subject to
complete the trial or sign informed consent

- Participation in another clinical trial within the past 30 days

- Other significant disease that in the investigator's opinion should exclude the
subject from the trial

- Legal incapacity or limited legal capacity

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:

PFS is defined as duration from randomization until radiological progression (based on Response Evaluation Criteria In Solid Tumors (RECIST)) or death due to any cause. Only deaths within 90 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.

Outcome Time Frame:

Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Sep 2010, until cut-off date expected Oct 2013

Safety Issue:


Principal Investigator

Medical Respobsible

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd, an affiliate of Merck KGaA, Darmstadt, Germany


China: Ministry of Health

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • Metastatic colorectal cancer
  • KRAS wild type
  • Cetuximab
  • First line treatment
  • First occurrence of metastatic colorectal cancer in Chinese subjects with KRAS wildtype
  • status
  • Colorectal Neoplasms