Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.
Phase 1
- Conditions
- Patients with metastatic or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000000502
- Lead Sponsor
- ational Cancer Center Hospital, Gastrointestinal Oncology Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1) Diabetes with regular use of insulin or under poor control 2) Active ischemic heart disease 3) Severe arrhythmia 4) Symptomatic brain metastasis 5) Alcohol allergy 6) HBs antigen positive or HCV antibody positive 7) Massive abdominal effusion 8) Massive pleural effusin 9) Severe diarrhea 10) History of other active malignancy 11) Pregnancy, the desire to preserve fecundity, or lactating woman 12) Severe mental disorder 13) Need of IVH or enteral nutrition 14) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I : Rate of dose limiting toxicity Phase II: Response rate
- Secondary Outcome Measures
Name Time Method Toxicity Time to treatment failure Overall survival