1) A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment.|
2) The patient has severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1).
3) The patient has peripheral neuropathy affecting the sensory nerves (Grade 1 or worse).
4) The patient has an active infection.
5) The patient has poorly controlled hypertension.
6) The patient has poorly controlled diabetes.
7) The patient has heart disease that may pose a problem.
8) The patient has severe pulmonary disease.
9) The patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction.
10) The patient has active gastrointestinal tract bleeding requiring repeated transfusions.
11) The patient is receiving phenytoin, warfarin potassium, or flucytosine.
12) The patient has moderate or more severe fluid accumulation in body cavities, such as pleural effusions and ascites, that continually requires treatment such as drainage.
13) The patient has brain metastasis or clinical features suggesting brain metastasis.
14) The patient has extensive bone metastasis (as determined by the patient’s primary physician).
15) The patient has watery diarrhea (watery stool) (Grade 2 or worse).
16) The patient has active multiple cancers.
17) The patient has a history of receiving platinum-based antineoplastic agents (e.g. oxaliplatin and cisplatin).
18) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner.
19) The patient tests positive for HBsAg or antibodies to HCV.
20) A patient who is deemed to need antiviral therapy for HBV-related hepatitis.
21) A lead investigator or the patient’s primary physician otherwise deems that participation in this trial is not appropriate for the patient.