Pancreatic cancer locally advanced unresectable or metastatic
Conditions
Interventions
Group I (experimental): 2 year treatment with Nimotuzumab 400 mg once a week (intravenous) until discontinuation criteria, in combination with Chemotherapy: Gemcitabine 1000mg / m2 (30 min intravenous
or Capecitabine 1000mg / m2 twice daily (oral), days 1-14, every 3 weeks
or combination 5-Fluouracil (5-Fu) 425mg / m2 (intravenous) (bolus) days 1-5 + folinic acid 20mg / m2 (intravenous) (bolus) days 1-5, every 4 weeks.
Antibodies, Monoclonal, Humanized
Capecitabine
Fluorouracil
Leucovorin
Antineoplastic Agents
Antibodies, Monoclonal
Administration, Intravenous
Administration, Oral
Nimotuzumab
Gemcitabine
Sponsors
Center of Molecular Immunology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Patient who provides written consent to participate in the study. 3. Patient with age equal to or greater than 18 years. 4. Life expectancy equal to or greater than 3 months. 5. Clinical status according to criteria of ECOG equal to or greater than 2 6. Patients receiving treatment with QT. 7. Laboratory parameters within the limits established in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patient pregnant, lactating or puerperal. 2. Patient with a second primary tumor. 3. Patient with chronic or uncontrolled intercurrent diseases (eg heart disease, diabetes, high blood pressure). 4. Patient with a history of hypersensitivity to any component of the formulation of Nimotuzumab or chemotherapy. 5. Patient who received Nimotuzumab or other biological therapy 6 months prior to enrollment or is receiving another research product. 6. Patient childbearing age who do not accept use appropriate contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Events related to Nimotuzumab (Adverse events classified as “serious” and with a causality relationship classified as “very likely, likely or possible” with the nimotuzumab). Measuring time: every 3 months until 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Regarding to Safety 1. Adverse events (AEs). Measurement time: every 3 months until 24 months. The AEs will be measured by: Type of EA (Name of EA) a) Seriousness of EA (Serious, not serious) b) EA intensity (mild, moderate, severe, threatening or disabling the patient's life and death) c) Causal relationship (very likely, likely, possible, unlikely, unrelated or non-evaluable) d) Attitude followed by the appearance of EA (temporary or permanent interruption, dose modification, unchanged) e) Treatment of AE (name of treatment indicated) f) Outcome of AE (reversible effect, irreversible effect, death or loss of patient follow-up) g) Batch of nimotuzumab (a batch number of nimotuzumab) 2. Clinical laboratory tests (values of every test parameter classified as “normal, not clinically significant and clinically significant”). Measuring time: before the CT cycle and, them every 3 months until 24 months. Regarding to effectiveness 1. Global survival (Time from recruitment until death from any cause. If not possible to assess the death of the patient, it will record the last patient news in the clinical health record). Measurement time: 6, 12, 18 y 24 months. 2. Progression-free survival (Time from treatment begin until objective tumor progression or death). Measurement time: 6, 12, 18 y 24 months. 3. Antitumor response (It will be evaluated like “Complete response, partial response, stable disease, disease progression” according to RECIST version 1.1 criteria). Measurement time: every 3 months after treatment begins until 24 months | — |
Countries
Cuba
Contacts
Public ContactYaimarelis Saumell Nápoles
Center of Molecular Immunology
Outcome results
None listed