None listed
Conditions
Interventions
ALIMTA plus GEMZAR Type of group
GEMZAR will be administered in doses of 1250 mg/m2 (days 1 and 8) and ALIMTA 500 mg / m2 (day 8). A maximum of 8 cycles will be carried out (one cycle equals 21 days).
Group name:GEMZAR Type of group
GEMZAR will be administered in a dose of 1000 mg / m2 (days 1, 8 and 15). There will be a maximum of 6 cycles (one cycle equals 21 days).
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body. You must have one tumor that can be physically measured or scanned by the doctor. You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU. You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis.
Exclusion criteria
Exclusion criteria: Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study. Documentation that the cancer has spread to your brain. Pregnant or breastfeeding. A second primary cancer. Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Global survival, progression of free survival, time to treatment failure, and duration of response to potential prognostic factors will be performed using Cox Proportional Hazard Model. Measure:To compare the overall survival in patients with unresectable pancreatic cancer in stage II-IV, in the treatment with combination therapy ALIMTA plus GEMZAR versus monotherapy in GEMZAR. Timepoints:21 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The EORTC QLQ-C30 is a reliable and valid instrument to assess the quality of life (QoL) in patients with cancer. Measure:Effects on health related to the quality of life Timepoints:21 day | — |
Countries
Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, Sweden, Taiwan, United Kindgdom, United States, Venezuela
Outcome results
None listed