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

NCT00933816 | Completed Phase 1 DMC

• 1 other identifier: JLOG0901
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

Brief 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

Hepatocellular Carcinoma

Keywords

sorafenib; intraarterial infusion chemotherapy; Low dose FP; cisplatin; fluorouracil

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity in phase I and Time to progression in Phase II

  Every 4 weeks

Secondary Outcomes (5)

• Phase I and II: Overall survival (OS)

  Every day

• Phase I and II: Progression free survival (PFS)

  Every four weeks

• Phase I: Time to progression (TTP)

  Every four weeks

• Phase I and II: Response Rate (RR)

  Every four weeks

• Phase I and II: Adverse effect (AE)

  Every four weeks

Study Arms (1)

Sorafenib with Low-dose FP

EXPERIMENTAL

Drug: sorafenib, cisplatin, fluorouracil

Interventions

sorafenib, cisplatin, fluorouracil DRUG

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.

Also known as: sorafenib with hepatic arterial infusion of low dose FP

Sorafenib with Low-dose FP

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kindai University: lead

Study Sites (3)

Kurume University Medical Center

Kurume, Fukuoka, 839-0863, Japan

Location

Ogaki Municipal Hospital

Oogaki, Gifu, 503-8502, Japan

Location

Kinki University School of Medicine

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines

Study Officials

• Masatoshi Kudo

  Kindai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

JP (3)