Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2015-02-13
• Target enrollment: 0
• Participant gender: All

Summary

To estimate the progression free survival for subjects treated with panitumumab in combination with a chemotherapy regimen of oxaliplatin, 5-Fluorouracil (5-FU) and leucovorin (FOLFOX) as first-line chemotherapy regimen for subjects with metastatic colorectal cancer with WT (wild type) KRAS according to the IGFRp (protein receptor insulin growth factor) and MMP-7 (Matrilysin) expression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
• Collaborators: Amgen; TFS Trial Form Support
• Treatments: Antibodies, Monoclonal; Fluorouracil; Leucovorin; Oxaliplatin; Panitumumab

Criteria

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