Advanced pancreatic cancer patients who get refractory to gemcitabine-based chemotherapy
Conditions
Interventions
Curcumin (8g/day) is orally added to gemcitabine-based chemotherapy until disease progression, unacceptable adverse events, patient withdrawal or death.
Sponsors
Kyoto University Hospital, Outpatient Oncology Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have histologically or cytologically confirmed carcinoma of the pancreas that is not amenable to resection with curative intent. 2. Patients who have failed gemcitabine-based therapy and no other therapy is available. 3. Age >/= 18 years and </= 80 years. 4. ECOG performance status </=1 5. Adequate oral intake is maintained. 6. Patients must have adequate organ and marrow function. 7. Patients present written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with interstitial pneumonia or pulmonary fibrosis. 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe infection. 4. Patients with history of severe drug allegy 5. Patients with other serious comorbid diseases 6. Patients with advanced cancer other than pancreatic cancer 7. Pregnant women or patients who wish pregnant 8. Patients with mental diseases 9. Patients who are judged inappropriate for the entry into the study by the investigater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I; Safety Phase II; Feasibility of complementary therapy using curcumin | — |
Countries
Japan
Outcome results
None listed