pancreatic cancer
Conditions
Interventions
CPT-11:100,125,150mg/m2 day1, L-OHP:85mg/m2 day1, q2w
Sponsors
Chiba cancer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma. (2)Refractory or intolerance for gemcitabine and 5-fluorouracil as previous chemothrapy. (3)Age;20 to 79 years old (4)ECOG PS;0-1 (5)Measurable lesions defined by RECIST. (6)Written informed consent. (7)Adequate organ function.
Exclusion criteria
Exclusion criteria: (1)Severe complications. (2)Grade2 or greater peripheral neuropathy. (3)Patients who received blood transfusions or hematopoietic growth factors within 7 days before the laboratory test (4)Active infections. (5)Pulmonary fibrosis or interstitial pneumonia. (6)Clinically evident pleural, abdominal or cardiac effusion. (7)Watery diarrhea within 3days before registration. (8)Surgery within 4weeks,chemotherapy within 2 weeks,radiation therapy within 2 weeks. (9)Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies. (10)Poorly controlled diabetes. (11)Brain metastasis. (12)Severe mental disorder. (13)Double advanced cancer. (14)Severe drug allergies. (15)pregnant or lactating female. (16)Current use atazanavir. (17)Concurrent chronic systemic steroid treatment. (18)Having UGT1A1*6/*6,UGT1A1*28/*28 or UGT1A1*6/*28 gene (19)Prior therapy with irinotecan or oxaliplatin. (20)Inappropriate for entry onto the study,as diagnosed by primary physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phaseI:Safety,frequency of DLTs phaseII:Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| phaseI:Response Rate frequency of adverse events phaseII:Overall Survival Progression-free Survival Disease Control Rate Safety | — |
Countries
Japan
Contacts
Public ContactAkiko Tsujimoto
Chiba cancer center Department of Gastroenterology
Outcome results
None listed