Patients with previously untreated and unresectable/recurrent colorectal cancer
Conditions
Interventions
UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest. CPT-11 150mg/m2/day is given intravenously on day 1 and 15 of each cycle
Sponsors
Department of Surgery, School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)colorectal cancer proven histologically 2) with measurable metastatic lesions 3) without prior chemotherapy or with chemotherapy which is completed before 6 months of registration 4) age: >=20 and <=75 5)Performance Status: 0-1 (ECOG) 6)more than 3 months of expected survival period 7)sufficient function of important organs a) WBC: >=3,500/mm3 and <12,000/mm3 b) Neutrophyl: >=2,000/ mm3 c) Platelet: >=100,000/ mm3 d) Hemoglobin: >=9.0 g/dl e) GOT, GPT: 2.5 times of normal range in each institute f) sT.bil: <=1.5 mg/dl g) sCreatinin: <=1.5 mg/dl h) normal ECG 8)written informed consent 9)with ability of oral intake
Exclusion criteria
Exclusion criteria: 1)with history of myocardial infarction, drug hypersensitivity within 6 months prior to the registration. 2) Prior ventral irradiation for colorectal cancer. 3)with active infection. 4)with intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, liver dysfunction, which disturb registration to this study. 5) Massive pleural or ascites that required drainage. 6)with brain metastasis. 7)with diarrhea. 8)with active double cancer. 9)patients receiving Flucytosine or Atazanabil. 10)with mental disorder which disturbs registration to this study. 11)pregnant or nursing women or women who like be pregnant. 12)men with partner willing to get pregnant. 13)patients receiving analgesic drug or steroids. 14)doctor's decision not to be registered to this study. In addition to the above-mention, patients who hope to use Bevacizumab together has to be checked about the following factors. 1)Urine dipstick for proteinuria should be <2+ 2)Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism. 3)Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks. 4) History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. 5) Long-term daily treatment with aspirin (>325 mg/day) 6) History of evidence of bleeding tendency or coagulopathy or defect of coagulation factor (INR>=1.5) or patient who taking anticoagulant agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step1 Toxicity Step2 Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Step2 Response rate, toxicity, Time to treatment failure, overall survival | — |
Countries
Japan
Contacts
Public ContactHirotoshi Hasegawa
Keio University School of Medicine Department of Surgery
Outcome results
None listed