advanced pancreatic cancer
Conditions
Interventions
None listed
Sponsors
Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patinents with histological or cytological evidence of pancreactic cancer(exclude of neuroendocrine tumor). Or,cytology is class 4,but clinically diagnosed pancreactic cancer. 2)Unresectable locally advanced or metastatic pancreatic cancer. 3)Patients aged more than 20 and less than 80. 4)Eastern Cooperative Oncology Group performance status of 0,1 5)That's ok there is not measurable lesion. 6)If patients who had a history of the following medications, more than 2 weeks have passed. chemotherapy:the last receiving day radiation:tha last radiation day. (We exclude radiation to the chest.) operation:tha last receiving day.(We exclude percutaneous transhepatic cholangio drainage.) 7)Patiens who have adequate hematological,renal and respiratory, heart function. a)Neutrophil count is more than 1500/mm3. b)Hemoglobin is more than 9.0g/dl c)Platlet is more than 100000/mm3 d)ALT/AST is less than 2.5 times upper limits of normal.In case of drainage of obstructive jaundice,less than 5 times upper limits of normal. e)T-Bil is less than 2.0mg/dl. f)sCr is less than 1.5 times upper limits of normal. 8)There is no interstitial lung disease on chest plain CT within 4 weeks. 9)Patients who have a life expectancy of at least 2 months. 10)Patinets who can hospitalization at least 4 weeks. 11)Informed consent can obtain from patients.
Exclusion criteria
Exclusion criteria: 1)Pregnancy,lactational woman.Man hope who's partner's pregnancy. 2)Patients who have a concurrent or previous interstitial lung disease, idiopathic pulmonary fibrosis, pneumoconiosis,drug-induced pneumonia. 3)Patients who have a concurrent or previous pulmonary emphysema or chronic obstructive pulmonary disease. 4)Patients who are after resection one lung. 5)Patients who have a history of radiation to the chest. 6)Patients who have received gemcitabine within 3 months. 7)Patients who had previously been exposed to EGFR inhibitor. 8)Patients who received transfusion within 4 weeks before registry. 9)Patients who have the follows digestive tract damage. patients who can't take a pill. patients wfo have active ulcer. 10)Patients who have clinically problematical oculus disease(serious xerosis,keratoconjunctivitis sicca, keratitis). 11)Patients who have symptomatic metastatic brain tumor. 12)Patients who have active bacterium or fungus infections. 13)Patients who have a concurrent clinically problematical heart disease(uncontroled hypertension,unstable angina, congestive heart failure,severe arrhythmia,myocarcial infraction within 12 months before registry). 14)Patients who have a current uncontroled diabetes mellitus. 15)Patients who have massive humor pool or edema. 16)Patiens who have previous severe drug-induced allergy. 17)In cases of doctor judged inappropriate for this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| genetic polymorphism relating interstitial lung disease events in patients receiving gemcitabine plus erlotinib | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival and progression free survival,validity,toxicity inpatients receiving gemcitabine plus erlotinib | — |
Countries
Japan
Contacts
Public ContactMeiko Nishimura
Kobe University Hospital Department of Medical Oncology and Hematology
Outcome results
None listed