Metastatic Colorectal Cancer
Conditions
Interventions
None listed
Sponsors
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria are mainly as follows (regardless of gender): 1. Has adenocarcinoma of the colon or rectum 2. Metastatic colorectal cancer 3. ECOG performance status of 0-1 4. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (refractory or intolerant to standard chemotherapy with FUs, L-OHP, CPT-11, bevacizumab as anti-VEGF antibody and cetuximab/patitumumab as anti-EGFR antibody) 5. Is able to take medications orally 6. Survival for at least 12 weeks is expected. 7. On the basis of tests carried out within 14 days before enrollment, which may be on the same day of the week as the enrollment date but 2 weeks earlier, the principal organ functions are maintained, as defined by the following criteria: a) Neurtophils>or=1500/mm3 b) Platelets>or=75,000/mm3 c) Hemoglobin>or=8.0g/dl d) GOT(AST)=or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis) e) GPT(ALT) =or<upper limit of normal (ULN)*2.5 (=or<ULN*5 in case of liver metastasis) f) Total bilirubin =or<upper limit of normal (ULN)*1.5 g) Serum creatinine =or<upper limit of normal (ULN)*1.5 8. Has provided written informed consent
Exclusion criteria
Exclusion criteria: The exclusion criteria are mainly as follows (regardless of gender): 1. Has synchronous multiple primary cancer within 5 years (except for carcinoma in situ ) 2.Taking CYP3A4 inhibitors or inducers(eg, phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole, macrolide antibiotics). 3. Has complication as follows a) poorly controlled diabetes b) uncontrolled hypertensions c) cirrhosis, liver failure, renal insufficiency d) intestinal paralysis, ileus e) interstitial lung disease, pulmonary fibrosis, emphysema f) active infection g) cardiac disease h) cerebrovascular disorder, brain metastasis i) hemorrhagic ulcer J) psychiatric disorder 4. Is a pregnant or lactating female 5. Amalgamation of mental disease or psychotic manifestation 6. The investigator considers not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint was to evaluate the association between SNPs of UGT1A9 and hand foot syndrome Grade 3. | — |
Countries
Japan
Contacts
Public ContactKazuo Kobayashi
Cancer Institute Hospital of the Japanese Foundation for Cancer Research Department of Pharmacy
Outcome results
None listed