Clinical trial NCT02246049 (phase 2, status: completed)
Conditions: colorectal neoplasms
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: 5-fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
SMILES: FC1=CNC(=O)NC1=O, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed consent.

          2. Histopathologically proven diagnosis of colorectal cancer (adenocarcinoma) excluding
             vermiform appendix cancer and proctos cancer.

          3. Not resectable metastatic colorectal cancer

          4. Age at enrollment is >= 20 and <= 75 years

          5. ECOG PS < 2 if age < 70 years, ECOG PS = 0 if age = 71-75 years

          6. One or more measurable lesion in RECIST ver.1.1 criteria according to contrast
             enhanced CT chest / abdomen / pelvis diagnosis.

          7. Not previously treated with chemotherapy. ( Previous adjuvant by fluoropyrimidine
             monotherapy is allowed if more than 24 weeks have elapsed between the end of adjuvant
             therapy and first relapse.)

          8. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. Data
             recorded nearest to the entry should be referred. Blood transfusion or erythropoiesis
             stimulating agents less than 2 weeks prior to the tests are not allowed.

             Neu. >= 1,500/cubicmillimeter Pt. >= 100,000/cubicmillimeter Hb. >= 9.0 g/dL T-bil. <=
             upper limit of normal (ULN)*1.5 AST and ALT,ALP <= upper limit of normal (ULN)*2.5 (<=
             ULN*5 in case of liver metastasis) Serum creatinine <= upper limit of normal (ULN)
             *1.5 PT-INR < 1.5 Proteinuria <= 2+

          9. UGT1A1 genotype tested. Categorized into Wild or single Hetero.

        Exclusion Criteria:

          1. Previously treated with irradiation to bone marrow constituting 20% or more of
             irradiation field.

          2. Untreated brain metastases or spinal cord compression or primary brain tumors.

          3. History of CNS disease.[except for asymptomatic Lacunar stroke]

          4. Requiring chronic systemic corticosteroid treatment.

          5. Current or recent ongoing treatment with anticoagulants.

          6. Clinically significant cardiovascular disease for example cerebrovascular accidents,
             myocardial infarction, unstable angina, congestive heart failure, serious cardiac
             arrhythmia requiring medication.

          7. Treatment with any investigational drug within 4 weeks.

          8. Patient with Uncontrolled hypertension, Uncontrolled diabetes, Uncontrolled diarrhea,
             >=grade 1 peripheral neuropathy, Active peptic ulcer, Non-healing wound, Clinically
             important diseases.

          9. Major surgical procedure within 28 days prior to study treatment start, open biopsy,
             or significant traumatic injury, or anticipation of the need for major surgical
             procedure.[except for implantation of central venous catheter and port system.]

         10. Lack of physical integrity of the upper gastrointestinal tract.

         11. Pregnant women, lactating woman , positive by pregnancy test , wishing to become
             pregnant, and Sexually active males.

         12. Hepatitis B or hepatitis C. Evidence of HIV infection.

         13. Previous Chemotherapy for other organs.

         14. Other active co-existing malignancies.

         15. History / Presence of thrombosis within 1 year requiring medication.

         16. History / Presence of paralytic ileus, obstruction or gastrointestinal perforation.

         17. Malignant coelomic fluid required drainage.

         18. History of allergy to Chinese hamster ovary cell proteins, or any of the components of
             the study medications.

         19. History of fluoropyrimidine severe side effects caused by DPD defect.

         20. Interstitial pneumonitis or pulmonary fibrosis.

         21. Evidence or requiring systemic treatment for Infectious disease.

         22. Patient who is judged by the investigator to be inappropriate for study participation
             for any reason.