Metastatic or recurrent colorectal cancer
Conditions
Interventions
Group I (Experimental): Nimotuzumab (hR3) 200 mg.
Grupo II (Experimental): Nimotuzumab (hR3) 400 mg.
Grupo III (Experimental): Nimotuzumab (hR3) 800 mg.
Grupo IV (Experimental): Nimotuzumab (hR3) 120
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with colorectal cancer diagnosed after received at least one chemotherapy regimen with oxaliplatin 2. Age greater than or equal to 18 years, of any gender or skin color 3. Patients with at least one measurable metastatic lesion, defined as those than can be measured using imaging techniques (CAT and/or NMR), before first line CT (as RECIST criteria, version 1.1). 4. Patients could have received chemotherapy, provided that such treatment had ended, at least, 4 weeks before being included in the study. 5. General status ECOG 0-2 6. Life expectancy of at least 12 weeks. 7. Patients comply with the requirements of the clinical laboratory: haemoglobin> 9 g/L, ALC >3 x 109 cells/L, platelets > 100 x 109/L, ANC= 1,5x109 /L, bilirubin <17 µmol/L, creatinine < 132 µmol/L, TGO/TGP<2.5 time upper normal limits. 8. Able and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with uncontrolled intercurrent illness including: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and psychiatric or social conditions that may limit adherence to clinical trial requirements. 2. Presence of brain metastasis. 3. Pregnancy or breastfeeding, or patients who refuse to use contraception during the study. 4. Patients that are receiving another investigational product. 5. Patients with history of hypersensitivity to this or any other similar biological product. 6. Patients previously treated with Monoclonal Antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AE) relating to the administration of Nimotuzumab (AE with causal relationship probable or very likely). Measuring time: in every administration until to complete 2 years of treatment. •Type of AE (name of the adverse event) •Duration of AE (Difference between of start date and the end date of the AE. May be in days, hours or minutes) •Intensity of AE (mild, moderate, severe, Life threatening, death related) •Serious AE (Severe/Serious, not serious/not serious) •Attitude from study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) •Result of AE (recovered, improved, persist, sequelae) •Causality of the adverse event (Certain, Probable /Likely, Possible, Unlikely, Unrelated) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response (Objective response and Antitumor Clinical Response). Objective response (Measurable disease and No measurable disease). Measuring Time: every 3 months until to complete 2 years of treatment. - Measurable disease (Complete Response, Partial Response, No change, Progression) - No measurable disease (Complete Response, Partial Response, Stabilization, Progression) Antitumor Clinical Response(Complete Response, Partial Response, Progressive Disease, Stable disease). Measuring Time: every 3 months until to complete 2 years of treatment. Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 2 years of treatment or progression date or death date. Global Survival. Time in months from the inclusion date until death or last date you have news. Measurement time: 2 years of treatment or death. EGFR expression (High, Moderate, Low, Negative). Measurement time: Before the treatment. KRAS expression (Mutated, Unmutated). Measurement time: Before the treatment. | — |
Countries
Cuba
Contacts
Public ContactPatricia Hernandez Casanna
Center of Molecular Immunology
Outcome results
None listed