- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933816
Study of Sorafenib In Combination With Low-dose 5-fluorouracil/Cisplatin (FP) Intraarterial Infusion Chemotherapy (SILIUS)
November 24, 2010 updated by: Kindai University
Phase I/II Study of Sorafenib In Combination With Low-dose FP Intraarterial Infusion Chemotherapy
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In Phase I, there will be 9 to 18 patients enrolled.
Cohorts of 3 to 6 patients will receive escalated dose of cisplatin and fluorouracil until the MTD is reached.
There will be no intra-patient dose escalation.
Sorafenib will be administered orally at a dose of 400mg bid for 28 days in the all patients.
Cisplatin at the dose of 10-20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 170-330mg/m2 will be administered continuously at day1-day5, 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.
At the end of each cycle, adverse effect will be evaluated and dose escalation will be determined.
In Phase II, there will be 28 patients enrolled.
Time to progression of this combination therapy at the recommended dose will be evaluated.
Study Type
Interventional
Enrollment (Anticipated)
37
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Fukuoka
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Kurume, Fukuoka, Japan, 839-0863
- Kurume University Medical Center
-
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Gifu
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Oogaki, Gifu, Japan, 503-8502
- Ogaki Municipal Hospital
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Osaka
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Osaka-Sayama, Osaka, Japan, 589-8511
- Kinki University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20 Years and older.
- Life expectancy of at least 12 weeks at the pre-treatment evaluation.
- Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.
- Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
- One treatment of hepatic arterial infusion chemotherapy without implanted catheter system is allowed.
- ECOG Performance status of 0 or 1.
- Cirrhotic status of Child-Pugh class A or B.
Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
- Hemoglobin 8.5 g/dl
- Granulocytes 1500/μL
- Platelet count 50,000 /μL
- PT-INR 2.3 or PT 6 seconds above control
- Total serum bilirubin 2 mg/dl
- AST(SGOT) and ALT(SGPT) 5 × upper limit of normal
- Serum creatinine 1.5 × upper limit of normal
- Amylase 5 × upper limit of normal
- Written Informed Consent must be obtained.
Exclusion Criteria:
- Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
- Renal failure
Any heart disease as follows
- Congestive heart failure defined as NYHA class III or IV
- Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening
- Serious cardiac arrhythmia
- Serious hypertension
- Active clinically serious infections.
- Active chicken pox.
- Auditory disorder.
- Known history of HIV infection.
- Known metastatic or meningeal tumors.
- Extrahepatic tumor spread.
- History of seizure disorder.
- Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
- Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization).
Any history of treatment as follows:
- Treatment with the agent which induces CYP3A4
- Surgical procedure within 4 weeks prior to start of study drug
- History of organ allograft
- Patients unable to swallow oral medications.
- Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
- Medication that may affect to the absorption of drug or pharmacokinetics.
- Any disease or disorder that may affect the evaluation of study drug.
- Entry to the other clinical trial within 4 weeks prior to entry to this study.
- Pregnant or breast-feeding patients.
- Known allergy to the investigational agent or any agent given in association with this trial.
- Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results.
- Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sorafenib with Low-dose FP
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity in phase I and Time to progression in Phase II
Time Frame: Every 4 weeks
|
Every 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase I and II: Overall survival (OS)
Time Frame: Every day
|
Every day
|
Phase I and II: Progression free survival (PFS)
Time Frame: Every four weeks
|
Every four weeks
|
Phase I: Time to progression (TTP)
Time Frame: Every four weeks
|
Every four weeks
|
Phase I and II: Response Rate (RR)
Time Frame: Every four weeks
|
Every four weeks
|
Phase I and II: Adverse effect (AE)
Time Frame: Every four weeks
|
Every four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Masatoshi Kudo, Kindai University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
July 1, 2009
First Submitted That Met QC Criteria
July 6, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
November 25, 2010
Last Update Submitted That Met QC Criteria
November 24, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- Cisplatin
- Fluorouracil
- Sorafenib
Other Study ID Numbers
- JLOG0901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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