Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer - KODK7 RPII

Department of Surgery, School of Medicine, Keio University0 sites72 target enrollmentDecember 19, 2007

ConditionsPatients with previously untreated and unresectable/recurrent colorectal cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Patients with previously untreated and unresectable/recurrent colorectal cancer
Sponsor: Department of Surgery, School of Medicine, Keio University
Enrollment: 72
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 19, 2007

End Date

June 15, 2015

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Department of Surgery, School of Medicine, Keio University

Eligibility Criteria

Inclusion Criteria

Not provided

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.