colorectal cancer
Conditions
Interventions
Patients received treatment for 12 weeks. CPT-11 was administered once every two weeks in 500 ml of normal saline or dextrose via 120-min intravenous infusion on day 1, 15, 29, 43, 57 and 71. 5-DFUR w
Sponsors
Department of Digestive Surgery and Surgical Oncology (Surgery II), and Department of Oncology and Laboratory Medicine, Yamaguchi University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were eligible for this study if they met the following criteria: proven unresectable or recurrent colorectal cancer; age between 20 and 75 years; no major surgery, radiotherapy or chemotherapy within 4 weeks prior to the study; Eastern Cooperative Oncology Group performance status of 0 to 2;predicted life expectancy of at least 3 months; adequate baseline organ functions, defined as a leukocyte count of at least 4,000/uL, neutrophil count of at least 2,000/uL, platelet count of at least 100,000/uL, hemoglobin of at least 9.0 g/dL, AST and ALT of 3 times or less the upper limit of the institutional reference range; total bilirubin below 1.5 mg/dL, and serum creatinine below 1.5 mg/dL.
Exclusion criteria
Exclusion criteria: Patients were ineligible if they had any of the following conditions: serious infectious disease or other severe complications (e.g., pulmonary fibrosis/interstitial pneumonia, uncontrollable diabetes); watery diarrhea, paralytic ileus, or intestinal obstruction; massive pleural effusion or ascitic fluid; symptomatic brain metastases; active concurrent malignancies; pregnancy or lactation, or desire for pregnancy; a history of drug allergy; and prior treatment with CPT-11.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: MTD, DLT, recomended dose | — |
Countries
Japan
Contacts
Public ContactShoichi Hazama
Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology (Surgery II)
Outcome results
None listed