advanced and/or metastatic gastric cancer
Conditions
Interventions
Docetaxel and TS-1 (DS):A course includes docetaxel 40 mg/m2 on day 1 and TS-1 80 mg/m2/day for 14 days followed by 7 days of interval. Patients undergo repeats of this 3 week therapy until diagnoses
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric cancer 2) with measurable lesions for RECIST criteria 3) Patients older than 75 years 4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5) Patients who can intake orally 6) Patients' labo data within normal range WBC:Between 4,000/mm3 and 12,000/mm3 Neutrocyte:More than 2,000/mm3 Hb:More than 8.0g/dL Platelet:More than 100,000/mm3 Total bil.:Less than 1.5mg/dL AST(GOT)ALT(GPT):Less than 2.5 times of upper normal range Ccr:More than 40 mL/min 7) Patients without any prior chemotherapy are eligible and patients without any adverse events due to prior chemotherapy completed before 6 months are also eligible. 8) A predicted life expectancy of at least 3 months. 9) Written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with active double cancers 2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, uncontrolled DM, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 3) Patients with ascites and/or pleural fluid 4) Patients with any symptoms due to metastases to the central nervous system 5) Patients with any fresh bleeding from digestive tract 6) with severe ischemic cardiac diseases or arythmia which needs treatments 7) Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray and/or CT 8) History of serious drug hypersensitivity due to 5-FU, Docetaxel or Polysolbate 80 9) Patients with severe dysfunction of kidney, bone marrow and/or liver 10) Patients who need flucitosine, fenitoin or walfarin 11) Patients with untreated edema 12) Any other patient whom the physician in charge of the study judges to be unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events/Incidence of AE. Overall survival Progression Free Survival Time to Treatment Failure | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Kinki University Faculty of Medicen Department of surgery
Outcome results
None listed