Colorectal cancer
Conditions
Interventions
CPT-11 150mg/m2(day1) Capecitabine Xmg/m2, p.o.(day2-8) to be repeated every 2 weeks for four course
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histologically proven colon or rectum cancer 2. Patients with tumor resistant to oxaliplatin after one or more courses of oxaliplatin treatment 3. Written informed consent 4. Age: 20-75 yo 5. Performance status: 0-2 (ECOG criteria) 6. A predicted life expectancy of at least 3 months. 7. With prior chemotherapy completed before more than 14 days 8. with sufficient bone marrow, renal or hepatic function WBC: 3,000 /mm3 <= and =< 12,000/mm3 Neutrocyte: 1,500/mm3=< Platelet: 100,000/mm3 =< Hemoglobin: 8.0 g/dl =< Total bilirubin: 1.5 >= GOT, GPT: 100 > Creatinine: 1.2mg/dl => Creatinine clearance : 60 <= 9. Ability of oral intake
Exclusion criteria
Exclusion criteria: 1) with treatments including CPT-11 2) with active double cancers 3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 4) Infectious disease 5) Diarrhea (watery stools) 6) with obstruction or disorder on digestive tract due to peritoneal metastasis 7) with ascites and/or pleural fluid 8) History of serious drug hypersensitivity 9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate. 10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion. 11) With liver cirrhosis or jaundice. 12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment. 13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment. 14) With diabetes that is difficult to control. 15) With central nervous system metastasis 16) Patients with UGT1A1 genotype *6/*6, *28/*28 and *6/*28 17) women pregnant, breast-feeding, or who wish pregnancy 18) Any other patient whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity, safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, overall survival, progression free survival, disease control rate | — |
Countries
Japan
Contacts
Public ContactNaotoshi Sugimoto
Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Outcome results
None listed