Trials / Completed
CompletedNCT00559455
Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective: To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV Secondary objective: To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxaliplatin | 85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks |
| DRUG | Fluorouracil | 400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks |
| DRUG | Leucovorin | 200mg/m², Day 1 and Day 2; Every 2 weeks |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2007-11-16
- Last updated
- 2011-06-28
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00559455. Inclusion in this directory is not an endorsement.