unresectable / recurrent gastric cancer
Conditions
Interventions
Docetaxel and Oxaliplatin and TS-1concurrent therapy : Level 1 Docetaxel : 32 mg/m2 i.v. (day1) Oxaliplatin : 105 mg/m2 i.v. (day1) TS-1 : 80 mg/m2/day p.o. (day1-14) to be repeated every 3 w
Sponsors
Keio University School of Medicine, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histological confirmation of gastric cancer. (2) Patients with an unresectable or recurrent gastric cancer. (3) Patients with confirmation of measurable or evaluable lesions within 28 days prior to entry. (4) No prior treatment of Docetaxel or Oxaliplatin or TS-1. (5) No prior treatment of radiation. (6) age: >=20 and <75 when received informed consent. (7) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 -1. (8) Life expectancy estimate 3 months, and more. (9) Vital organ functions (listed below) are preserved within 14 days prior to entry. Neutrophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=8.0 g/dl AST and ALT <=100 I/U Total bilirubin<=1.5 mg/dl Serum creatinine <= 1.2 mg/dl Estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min (10) Patients able to oral intake (11) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with severe ischemic heart disease or arhythmia. (2) Patients with myocardial infarction within 6 months. (3) Patients with liver cirrhosis or active hepatitis. (4) Patients with dyspnea needing oxygen. (5) Patients with fresh gastrointestinal bleeding which require a repeat blood transfusion. (6) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication. (7) Patients with uncontrolled diabetes mellitus. (8) Patients with ileus or subilues. (9) Patients with fever infection. (10) Patients who have history of active simultaneous or metachronous double cancers within 5 year. However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer. (11) Patients with CNS metastases. (12) Patients with acute infectious diseases. (13) Patients with peripheral neuropathy. (14) Patients with history of severe adverse event suspected to be caused by drugs. (15) Patients with history of severe adverse event suspected to be caused by Polyoxyethylene Castor Oil or hydroxyohlorinatedcasteroil. (16) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers. (17) Patients who are inappropriate for the study at the physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response rate | — |
Countries
Japan
Contacts
Public ContactHirofumi Kawakubo
Keio University School of Medicine Department of Surgery
Outcome results
None listed