Metastatic Colorectal Cancer
Conditions
Interventions
Lonsurf/L-OHP therapy Lonsurf: 70mg/m2, d1-5, d15-19 (fixed dose) L-OHP: 50-85mg/m2, d1,d15 (dose escalation) every 4 weeks
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 (except for appendiceal cancer and anal cancer) 3. Has evaluable tumor lesions (RECIST ver. 1.1) 4. Aged 20 to 80 years at the time of informed consent 5. ECOG performance status of 0 or 1 6. 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) 7. Is able to take medications orally 8. Survival for at least 12 weeks is expected. 9. 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=100,000/mm3 c) Hemoglobin>or=9.0g/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 10. Has provided written informed consent
Exclusion criteria
Exclusion criteria: The exclusion criteria are mainly as follows (regardless of gender): 1. Has received Lonsurf 2. History of discontinuation for adverse reaction (eg. serious peripheral neuropathy) by L-OHP 3. History of drug hypersensitivity (except for L-OHP) 4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 5. Has bleeding from the tumor which affect hemodynamics 6. Has sever peripheral neuropathy 7. Has synchronous multiple primary cancer within 5 years (except for carcinoma in situ ) 8. Ascites, pulmonary and/or pericardial effusion requiring medical treatment 9. 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 10. Is a pregnant or lactating female 11. History of severe allergy 12. Amalgamation of mental disease or psychotic manifestation 13. The investigator considers not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part]Disease Control Rate (DCR) | — |
Countries
Japan
Contacts
Public ContactMitsukuni Suenaga
Cancer Institute Hospital of the Japanese Foundation for Cancer Research Gastroenterology
Outcome results
None listed