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Phase II Clinical Study of Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favourable FcγR IIa (CD32) Genotype

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

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Trial Information

Phase II Clinical Study of Cetuximab in Refractory Colorectal Cancer With K-RAS Mutated and Favourable FcγR IIa (CD32) Genotype

Inclusion Criteria:

- Written informed consent form signed by the subject

- Age greater than or equal to (>=) 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(=<) 2

- Life expectancy of greater than 2 months

- Histological confirmed colorectal cancer (CRC) with mutated K-RAS and favorable
genotypes (any H in FcγRIIa-131). Selection will be done only based on Cluster of
differentiation (CD)32 polymorphisms

- Epidermal growth factor receptor (EGFR) expression in his/her tumor sample

- Stage 4 metastatic disease, with at least one measurable lesion according to RECIST
v1.1 criteria, documented within 28 days prior to the study inclusion

- Tumor tissue sample available for the assessment of K-RAS status and FcγRIIa (CD32)

- Subject who has received at least 2 prior therapeutic lines

- Adequate bone marrow function, defined as:

- hemoglobin greater than (>) 9.0 gram per deciliter (g/dL)

- platelet count >100 * 10^9 per liter (/L)

- absolute neutrophil count (ANC) >=1.5 * 10^9/L

- Adequate hepatic and renal function, defined as:

- Serum bilirubin =<1.5 times the upper limit of normal (ULN)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 * ULN
in absence of liver metastasis and ALT and AST =<5 * ULN in the presence of
liver metastasis

- Alkaline phosphatase =<2.5 * ULN or =<5 in the presence of liver metastasis or
=<10 in the absence of liver metastasis

- Creatinine clearance >= 50 milliliter per minute (ml/min) (according to
Cockcroft and Gault formula) or serum creatinine <1.5 * ULN

- Adequate recovery after recent surgery, chemotherapy or radiotherapy. Prior major
surgery, chemotherapy, treatment with an investigational product or radiotherapy must
have occurred at least 4 weeks before study inclusion

- Women of child-bearing potential must have a negative pregnancy test performed within
7 days prior to the study inclusion. Postmenopausal women must be amenorrheic for at
least 12 months. If the risk of conception exists both male and female subjects must
use effective contraception (for example, abstinence, intrauterine device (IUD), oral
contraceptive, double barrier method or to be surgically sterile) since the signature
of the consent form until at least 6 months after the end of treatment or end of last
dose, whichever occurs first

Exclusion Criteria:

- Previous treatment with monoclonal antibodies against EGFR

- Toxicity, due to previous treatment, not resolved to Grade 1 before the subject's
inclusion into the study

- Clinically relevant coronary disease or myocardial infarction, unstable angina, Grade
>=2 congestive cardiac insufficiency according to New York Heart Association (NYHA)
within 6 months before starting the study treatment

- Clinically significant vascular disease (for example, aortic aneurysm which requires
surgery, pulmonary embolism, recent peripheral arterial thrombosis) within 12 months
prior to starting the study treatment

- Evidence of uncontrolled brain metastases

- History of active neurological disease

- History of uncontrolled seizures

- History of lung fibrosis, acute pulmonary damage or interstitial pneumonia

- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
infection, or presence of severe, uncontrolled intercurrent infections or other
severe uncontrolled concomitant diseases

- Current Grade >=2 (National Cancer Institute Common Terminology Criteria for Adverse
Events [NCI-CTCAE]) infection

- History of uncontrolled diabetes, uncontrolled hypertension or hepatic involvement

- Known or suspected allergy or hypersensitivity to cetuximab

- History of previous malignancy other than CRC occurring within 5 years before
starting the study treatment, except for previously cured basal cell carcinoma of
skin or carcinoma in situ of the cervix or urinary bladder treated more than 2 years
before recruitment

- Participation in another treatment study with an investigational drug within the last
30 days

- Pregnancy or lactation

- Any medical, psychological, psychiatric or social uncontrolled problem which may
interfere in the participation of the subject in the study or in the evaluation of
the study results

- Psychological, familiar or geographic conditions not allowing the adequate follow-up
and adherence to the study protocol

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS) time

Outcome Time Frame:

Time from randomization to death, reported between day of first subject randomized up to 2 years

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Merck, S.L., Spain


Spain: Spanish Agency of Medicines

Study ID:

EMR 062202-529



Start Date:

September 2011

Completion Date:

August 2014

Related Keywords:

  • Colorectal Cancer (CRC)
  • K-RAS
  • FcγRII/IIIa genotypes
  • CRC
  • Colorectal cancer
  • Colorectal Neoplasms