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Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion Chemotherapy

NCT00933816 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2010-11-25

No results posted yet for this study

Summary

The purpose of this study is to determine the recommended dose of the combination therapy of sorafenib with hepatic arterial infusion of low dose cisplatin and fluorouracil on patients with advanced hepatocellular carcinoma (Phase I), and to evaluate the efficacy of this combination therapy in the recommended dose (Phase II).

Conditions

Interventions

DRUG

sorafenib, cisplatin, fluorouracil

Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in the all patients. Cisplatin at the dose of 10-20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days and 3 cycles of this combination therapy will be continued.

Sponsors & Collaborators

  • Kindai University

    lead OTHER

Principal Investigators

  • Masatoshi Kudo · Kindai University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933816 on ClinicalTrials.gov