Colorectal Cancer
Conditions
Interventions
5-FU, CPT-11, Bevacizumab
Sponsors
National Cancer Center Hospital, Gastrointestinal Oncology Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Inoperable, locally advanced and/or metastatic colorectal cancer 2) Histologically confirmed adenocarcinoma, mucinous adenocarcinoma or signet-ring cell carcinoma 3) Age 20 to 75 4) Performance status 0-2(ECOG) 5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 6) Have prior chemotherapy as first line treatment 7) No prior CPT-11 and bevacizumab administration 8) Urine dipstick for proteinuria should be<2+ 9) Adequate function of major organs as defined below: Hb >8.0g/dl WBC 3,000-12,000/ul Platelet >100,000/ul Bilirubin <1.5 mg/dL GOT and GPT <100 IU/L Creatinine <1.5 mg/dL 10) Voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Serious drug hypersensitivity or a history of drug allergy 3) Active infections 4) Serious complications (e.g., intestinal tract paralysis, ileus, pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure or hepatic failure.) 5) Uncontrolled hypertension 6) Abnormal EKG 7) Severe ascites 8) Metastasis to the CNS 9) History or evidence of inherited bleeding diathesis 10) Coagulopathy with the risk of bleeding 11) Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism 12) HBs Ab positive, HCV At positive 13) Uncontrolled watery diarrhea 14) Major surgical procedure within 4 weeks 15) Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. 16) Judged ineligible for participation in the study by the investigator for safety reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of overall response rate (ORR; complete response [CR] + partial response [PR]). | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of overall survival (OS), progression free survival. time to treatment failure and safety. | — |
Countries
Japan
Contacts
Public ContactYoshinori Hirashima
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed