Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer (PULSE)

This is an interventional treatment trial for Metastatic Colorectal Cancer Read More

Inclusion Criteria:

• Man or woman ≥ 18 years.
• Competent to comprehend, sign, and date an IEC-approved (Ethics Committee) informed consent form
• Histologically-confirmed metastatic adenocarcinoma of the colon or rectum by the investigator.
• Wild Type K-RAS colorectal cancer determined by the designated Central Laboratory prior to inclusion in the study in the primary tumor and/or at least one metastasis.
• At least 1 uni-dimensionally measurable lesion of at least > 10 mm with spiral CT per modified RECIST criteria 1.1. (Response Evaluation Criteria In Solid Tumors)

• Patients with the following characteristics will be included:

  1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with a disease-free interval > than 6 months after its completion.
  2. Recurrence after adjuvant treatment with oxaliplatin +/- radiotherapy with a disease-free interval > than 12 months
  3. De novo diagnosis of the disease.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Life expectancy ≥ 3 months
• Adequate bone marrow function
• Adequate Hepatic and metabolic functions
• Adequate Renal function
• Magnesium > LLN (Lower limit of Normal)

Exclusion Criteria:

• Patients they have received prior systemic therapy for the treatment of metastatic colorectal carcinoma.
• Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib) or EGFR signal transduction inhibitors.
• Patients who had resection of metastatic disease
• Central nervous system/brain metastases
• Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
• Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
• Presence of peripheral neuropathy (Common Toxicity Criteria (CTC) version 3.0 > grade 1), and of serious nonhealing wound, ulcer, or bone fracture.
• Hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
• Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
• Treatment for systemic infection within 14 days before initiating study treatment
• Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day).
• Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
• Any investigational agent within 30 days before enrollment
• Subject who is pregnant or breast feeding
• Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 14 days prior to inclusion in the study.
• Woman or man of childbearing potential not consenting to use adequate contraceptive precautions