PhaseI/II study of irinotecan and oxaliplatin combination chemotherapy in patients with gemcitabine and 5-fluorouracil refractory pancreatic cancer.
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-UMIN000015877
- Lead Sponsor
- Chiba cancer center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method