Metastatic pancreatic cancer. Malignant neoplasm of pancreas
Conditions
Interventions
The intervention group will receive gemcitabine manufactured by Acteropharma pharmaceutical company as an intravenous infusion at a dose of 1 g/m2 on days 1, 8, and 15 from the start of the interventi
Sponsors
Vice Chancellery of Research and Development of Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of metastatic pancreatic cancer based on histopathology findings. Patients with disease recurrence or progression in response to first-line treatment for metastatic pancreatic cancer. Patients over 18 years old. Patients with a Performance Status (PS) of 0 to 2, according to ECOG criteria, or above 50 percent, according to Karnovsky PS. Patients with the ability to swallow. Consent of the patient or the patient's legal guardian to participate in the study.
Exclusion criteria
Exclusion criteria: Patients with severe liver failure. (Child-Pugh class B or C) Patients with severe renal dysfunction (Creatinine clearance < 20 ml/min). Patients with bone marrow dysfunction. Patients with history of myocardial infarction within 6 months prior to the start of the study or history of heart failure or cardiac arrhythmias. Patients with active interstitial lung disease. Patients with active infection. Pregnant and breastfeeding women. Patients with concomitant use of antiepileptic drugs that induce cytochrome p450 enzyme.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size. Timepoint: Before intervention and one week after completion of intervention. Method of measurement: CT scan radiology report.;Cancer Antigen 19-9. Timepoint: Before intervention and one week after completion of intervention. Method of measurement: Electro chemiluminescence immunoassay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication adverse event profile. Timepoint: Before intervention and 1, 2 and 3 months after the start of intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDena Firouzabadi
Shiraz University of Medical Sciences
Outcome results
None listed