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Phase 2
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

Inclusion Criteria:

1.1 Inclusion criteria for pre-screening phase:

- Untreated advanced metastatic colorectal cancer patients

- Adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin
embedded tissue sections and one corresponding HE stained slide or a FFPE tumor

1.2 Inclusion criteria for treatment phase:

Patients must fulfill all criteria listed below prior to enrolment in the study:

- Untreated wild-type KRAS metastatic colorectal cancer

- Previous adjuvant therapy must have been completed > 6 months before therapy
initiation on this study

- Age >18 years

- Measureable disease with CT or MRI

- ECOG performance status of 0-2

- Adequate organ function

- Hematologic:

- Absolute neutrophil count > 1,500/µL

- Hemoglobin >9 mg/dl

- Platelet count >100,000 /µl

- Renal:

- Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance
> 30 ml/min

- Hepatic:

- Serum bilirubin < 1.5 mg/dl

Exclusion Criteria:

- Creatinine clearance below 30 ml/min

- Patients with a history of other malignancies within 2 years prior to study entry,
except for adequately treated carcinoma in situ of the cervix; basal or squamous cell
skin cancer; low grade, early stage localized prostate cancer treated surgically with
curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with
curative intent.

- Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or
IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias
requiring ongoing treatment, or unstable angina.

- Other known co-morbidity with the potential to dominate survival

- Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any
of the applied drugs

- Pregnant or breast feeding women

- Any co-existing medical or psychological condition that would preclude participation
in the study or compromise ability to give informed consent.

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

Treatment response according to Response Evaluation Criteria In Solid Tumors [RECIST]

Outcome Time Frame:

5 years

Safety Issue:



Austria: Agency for Health and Food Safety

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • metastatic colorectal cancer
  • mCRC
  • ERCC-1
  • ERCC1
  • AGMT
  • Colorectal Neoplasms