Metastatic colorectal cancer
Conditions
Interventions
S-1+CPT-11+bevacizumab+Placebo S-1 80-120mg/day day1-14 q4w CPT-11 100mg/m2 day1,15 q4w Bevacizumab 5mg/kg day1, 15 q4w Placebo day1-28 q4w
S-1+CPT-11+bevacizumab+hange-shashin-to S-1 80-120mg/
Sponsors
NPO Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer (adenocarcinoma) except for appendiceal cancer 2) Unresectable or recurrent colorectal cancer 3) Age of 20 years or older 4) ECOG Performance status of 0-2 5) Measurable or evaluable lesions 6) Received prior Oxaliplatin-containing first line chemotherapy 7) Sufficient oral intake 8) Sufficient major organ functions below: Neutrophil count >= 1,500 /mm3 Platelet count >= 100,000 /mm3 Hemoglobin >= 9.0 g/dL AST <= 100 IU/L ALT <= 100 IU/L Total bilirubin <= 1.5 mg/dL Serum creatinine <= 1.2 mg/dL Creatinine clearance >= 60 mL/min Urine protein <= Grade 1 9) Life expectancy of at least 3 months 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of severe drug allergies except for ones related by Oxaliplatin 2) Received radiation therapy to the abdomen 3) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less). Carcinoma in situ decided cure by treatment, differentiated gastric mucosal cancer or skin cancer will be permitted for registration 4) Active infections 5) Gastrointestinal perforation, Paresis of intestine, Ileus induced by bevacizumab 6) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure and so on. 7) Aldosteronism, myopathy 8) Severe hypokalemia 9) Ascites or pleural effusion requiring treatment 10) Watery diarrhea 11) Current use of flucytosine and/or atazanavir 12) Current use of drug for controlling intestinal function such as Lactomin or Bifidobacterium preparation 13) Symptomatic brain metastasis 14) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 15) Severe mental disorder 16) Thrombosis, cerebral infarction, myocardial infarction, lung infarction within 6 months before enrollment 17) Surgery and/or biopsy with surgical incision within 4 weeks except for placement of central venous access port 18) Homozygous genotype of UGT1A1*28 or UGT1A1*6, and double heterozygous genotype of UGT1A1*28 and UGT1A1*6 19) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3 or more diarrhea until the end of 3rd cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Progression Free Survival Time to Treatment Failure Overall Survival Incidence and severity of adverse events Dose intensity Frequency of rescue medication for diarrhea Compliance | — |
Countries
Japan
Contacts
Public ContactYoshito Komatsu
Hokkaido University Hospital Department of Cancer Chemotherapy
Outcome results
None listed