Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Phase 1
- Conditions
- Esophageal cancer
- Registration Number
- JPRN-UMIN000013627
- Lead Sponsor
- ippon Medical School Musashi Kosugi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
Poor control DM, active other cancer, the past history of hyper sensitivity of study drugs, active infection, continuous use of steroid, peripheral neuropathy greater than CTCAE-Grade 2, active interstitial pneumonia, pulmonary fibrosis, psychiatric disorder, cardiopulmonary disorder(past history of angina in less than 4 weeks, myocardial infarction in less than 6 monthes, poor control congenitive heart failure), untolerable alcohol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I The maximum tolerated dose,recommended dose, and dose-limiting toxicities of weekly paclitaxel administration Phase II Response Rate of triweekly FP(5-fluorouracil plus cisplatin) and weekly paclitaxel (PCF).
- Secondary Outcome Measures
Name Time Method Phase I Adverse events, and response rate of PCF Phase II Curative setting group(potentially resectable) Adverse events, pathological CR rate, progression free survival, and overall survival of PCF Palliative setting group(potentially unresectable) Adverse events, progression free survival, and overall survival of PCF