EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer

The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis

* Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease
* Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment
* At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (\>=) 2 centimeter (cm) by conventional techniques or \>=1 cm by spiral computed tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) \>= 80 percent (%)
* Absolute Neutrophil Count (ANC) \>=1.5 x 10\^9/Liter
* Platelets \>=100 x 10\^9/Liter
* Hemoglobin \>=9 gram per deciliter (g/dL) (without transfusions)
* Bilirubin less than or equal to (\<=) 1.5 x upper limit normal (ULN)
* Aspartate transaminase (AST) \<=5 x ULN and alanine transaminase (ALT) \<=5 x ULN
* Serum creatinine \<=1.25 x ULN and/or creatinine clearance \>=50 milliliter per minute (mL/min)
* International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits
* Sodium and potassium within normal limits or \<=10% above or below (supplementation permitted)

Exclusion Criteria:

* Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (EGFR)
* Known brain metastasis and/or leptomeningeal disease
* Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry; planned major surgery during the trial
* Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed)
* Clinically relevant coronary artery disease (New York Heart Association \[NYHA\] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
* Uncontrolled hypertension defined as systolic blood pressure \>=160 millimeter of mercury (mmHg) and/or diastolic blood pressure \>=100 mmHg under resting conditions
* History of coagulation disorder associated with bleeding or recurrent thrombotic events
* History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start
* Chronic inflammatory bowel disease, or acute/chronic ileus
* Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection