Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer (PULSE)
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility 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:
- Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with a disease-free interval > than 6 months after its completion.
- Recurrence after adjuvant treatment with oxaliplatin +/- radiotherapy with a disease-free interval > than 12 months
- 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
Sites / Locations
- Hospital General Universitario de Elche
- Hosptial General de l'Hospitalet de Barcelona
- Corporació Sanitaria Parc Taulí de Barcelona
- Hospital de l'Esperit Sant
- Consorcio Hospitalario Provincial de Castellon
- Hospital Son Espases de Mallorca
- Hosptial Son Llatzer de Mallorca
- Hosptial de Logroño
- Hospital Universitario La Paz de Madrid
- Clínica Universitaria de Navarra
- Hospital de Navarra
- Hospital Xeral Cies de Vigo
- Hospital Clínic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau de Barcelona
- Complejo Asitencia de Burgos. Hospital General Yague
- Hospital General de Ciudad Real
- Institut Català d'Oncologia (ICO) de Girona
- Centro Oncológico de Galícia
- Hosptial Dr. Negrin de Las Palmas de Gran Canaria
- Hospital Arnau de Vilanova de Lleida
- Hospital Infanta Sofía de Madrid
- Hospital Universitario Puerta de Hierro de Madrid
- Hospital de Fuenlabrada de Madrid
- Hospital Morales Meseguer
- Hosptial de Sant Pau i Santa Tecla de Tarragona
- Hospital La Fe de Valencia
- Instituto Valenciano de Oncología de Valencia
- Hospital General de Valencia
- Hospital Dr. Peset de Valencia
- Hospital Miguel Servet de Zaragoza
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Panitumumab + FOLFOX (DP)
Panitumumab + FOLFOX (no-DP)
Panitumumab and FOLFOX will be administered to patients with DP (MMP7+/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.
Panitumumab and FOLFOX will be administered to patients with no-DP (MMP7+/p-IGF-IR-, MMP7-/p-IGF-IR+ or MMP7-/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.