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Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following: * how effective this combination of study drugs will be in treating HCC * how long subjects respond to these study drugs * what types of side effects can be expected, and * how severe the side effects are All subjects in this study will receive: * Sorafenib twice a day by mouth * Capecitabine twice a day by mouth Treatment will be given in a 28-day treatment cycle. Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle
Details
| Lead sponsor | New Mexico Cancer Research Alliance |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 15 |
| Start date | 2009-09 |
| Completion | 2017-08 |
Conditions
- Hepatocellular Carcinoma
Interventions
- Sorafenib & Capecitabine
Primary outcomes
- Number of Participants Experiencing Adverse Events — 6 months
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.
Countries
United States