Metastatic colorectal cancer, left-sided, unresectable
Conditions
Interventions
Nimotuzumab group (experimental): Monoclonal antibody nimotuzumab (200 mg, intravenously) + FOLFOX (FOLFOX4, FOLFOX6, or mFOLFOX6) for 12 treatment cycles, every 15 days for 24 weeks.
FOLFOX group (co
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Drug Therapy
Oxaliplatin
Leucovorin
Antineoplastic Agents
Administration, Intravenous
Nimotuzumab,
FOLFOX
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who provide written informed consent 2. Patients who meet the diagnostic criteria. 3. Patients of either sex, between 18 and 75 years of age 4. Patients with metastatic disease, with at least one measurable metastatic lesion according to the Response Evaluation Criteria in Solid Tumors RECIST v 1.1 5. Clinical status according to ECOG between 0 and 2 6. Life expectancy of at least three months 7. Normal hematological, renal, hepatic, metabolic, and coagulation function defined by: - Hemoglobin = 90 g/L (patients with lower Hb levels should be transfused prior to inclusion) - Total Leukocyte Count = 3.0 x 109/L - Absolute Neutrophil Count = 1.5 x 109/L - Platelet Count = 100 x 109/L - Bilirubin up to the upper limit of normal. - SGPT and SGOT: up to =1.5 times the institution's upper limit of normal, or 50 mL/min/1.73 m2 for patients with creatinine levels above the institution's normal.
Exclusion criteria
Exclusion criteria: 1. Having received prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma. 2. Having received prior chemotherapy for the primary tumor within six months prior to starting treatment. 3. History of central nervous system (CNS) metastases. 4. Prior treatment with epidermal growth factor receptor (EGFR) inhibitors. 5. Patients with acute infectious, chronic, or decompensated inflammatory diseases, including, but not limited to: clinically significant cardiac disease, clinically significant peripheral sensory neuropathy, active inflammatory bowel disease, recent active or uncontrolled gastroduodenal ulcer, history of interstitial lung disease, recent pulmonary embolism, deep vein thrombosis or other significant venous event, bleeding diathesis, and/or preexisting coagulopathy, with the exception of well-controlled anticoagulant therapy. 6. Major surgical procedure performed three months prior, open biopsy, or significant traumatic injury that has not yet recovered from prior major surgery. 7. Known or suspected allergy or hypersensitivity to any component of the chemotherapy or the investigational product. 8. Pregnant or breastfeeding women. 9. Patients of childbearing age who do not agree to use adequate contraceptive methods (intrauterine devices, barrier methods or tubal ligation, hormonal methods).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (Time from randomization until date of disease progression or death from any cause). Measurement time: every 3 months, for a period of 3 years, measured from the patient's inclusion in the trial. 2. Adverse Events- AE (Occurrence of any AE (Yes, No), Type of AE (It will be classified according to the classification established by the CTC (Common Toxicity Criteria) version 5.0 of the US National Cancer Institute), Duration of the AE (Time from the onset and the end of the adverse event), Intensity of the AE (It will be assessed according to the criteria established by the CTC (Common Toxicity Criteria) version 5.0 of the US National Cancer Institute as 1. Mild, 2. Moderate, and 3. Severe), Causal relationship (1. Definite, 2. Very probable, 3. Probable, 4. Possible, 5. Unrelated, 6. Unknown), Severity (Severe/serious, Non-serious/non-serious), Treatment response (1. No change, 2. Dose modification, 3. Temporary interruption, or 4. Permanent discontinuation), Outcome of the AE (1. Recovered, 2. Improved, 3. Persistent, or 4. Sequelae.)). Measurement time: from randomization until 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (Time measured from the date of inclusion in the study to the date of death. If the patient's death is uncertain, the time elapsed until the date the last patient update is recorded in the medical record will be recorded). Measurement time: From inclusion in the trial to death or last contact. 2. Objective response (RECIST 1.1 criteria, which subclassifies objective response into: a) complete response; b) partial remission; c) stable disease; and d) progressive disease). Measurement time: 3 months, 6 months, 12 months, 18 months, 24 months, and progression. 3. EGF-R expression. This refers to the tissue expression of the protein epidermal growth factor receptor, determined by immunohistochemical technique on formaldehyde-fixed, paraffin-embedded (FFEP) tissue blocks in tumor tissue from patients using colonoscopy. Scale: a) Negative, b) Positive +, c) Positive ++, and d) Positive +++. Measurement time: (D 0) before the start of treatment. 4. KRAS mutation status (Type of anomalous variant of the transcription factor KRAS, a protein responsible for the phosphorylation of several intracellular signal transduction pathways relevant to cancer, determined by molecular biology techniques from liquid biopsies obtained from peripheral blood and measured as a) Mutated, b) Not mutated). Measurement time: Before the start of treatment. | — |
Countries
Cuba
Contacts
Public ContactGeidy Lorenzo Monteagudo
Center of Molecular Immunology (CIM)
Outcome results
None listed