Gastric cancer
Conditions
Interventions
5-FU 500-600mg/m2 days 1, 8, 15 l-Leucovorin 250mg/m2, days 1, 8, 15 Paclitaxel 60-80mg/m2, days 1, 8, 15 Every 28 days
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Unresectable or recurrent gastric cancer 2. Histologically confirmed adenocarcinoma 3. Peritoneal metastasis with massive ascites or inadequate oral intake 4. with or without measurable lesion 5. Age 20-80 years 6. PS 0-2 7. First line chemotherapy or prior chemotherapy went as follows: a) recurrence within 6 months after, or during adjuvant chemotherapy, b) progression after continuous infusion of 5-fluorouracil and c) progression after oral fluoropyrimidine-based chemotherapy 8. No previous chemotherapy or radiotherapy for other than gastric cancer 9. Preserved organ functions 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Uncontrollable diabetes mellitus 2. Uncontrollable heart disease 3. Other severe complications such as renal failure, liver failure and intestinal pneumonitis 4. Symptomatic CNS metastasis 5. History of hypersensitivity to alcohol 6. Prior taxane-containing chemotherapy 7. Active bacterial or fungous infection 8. Massive pleural effusion 9. Severe diarrhea 10. Active bleeding 11. Active double cancer 12. Pregnancy, the desire to preserve fecundity, or lactating woman 13. Severe mental disorder 14. Patient evaluated to be inadequate by a attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: Incidence of dose limiting toxicity Part II: Proportion of patients who completed 2 cycles of the protocol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, Response rate, Response for ascites, Overall survival, Progression-free survival, Time to treatment failure | — |
Countries
Japan
Contacts
Public ContactTakako Eguchi Nakajima
National Cancer Center Hospital Gastrointestinal Oncology Division
Outcome results
None listed