Phase I/II trial of hepatic arterial infusion of FMP therapy for advanced hepatocellular carcinoma

UMIN ID: UMIN000000487

Registered date:12/09/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced hepatocellular carcinoma
• Date of first enrollment: 2005/10/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): FMP therapy: The therapy consists of intraarterial administration of cisplatin and mitoxantrone on day 1, and continuous intraarterial infusion of 5-fluorouracil on days 1 through 5. The treatment is repeated every four weeks for a maximum of six courses if there is no evidence of tumor progression or unacceptable toxicity. Dosage level[5-fluorouracil, mitoxantrone, cisplatin (mg/m2)] Level -1 [300, 4, 50] Level 0 [300, 4, 60] Level 1 [400, 4, 60] Level 2 [400, 6, 60] Level 3 [500, 6, 60]

Outcome(s)

• Primary Outcome: Phase I: frequency of dose-limiting toxicities Phase II: response rate and adverse events at the recommended dose
• Secondary Outcome: Progression free survival, overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Prior chemotherapy with 5-fluorouracil, mitoxantrone, and cisplatin for hepatocellular carcinoma 2) Refractory pleural effusion or ascites 3) Allergic reaction to iodine contrast material 4) Severe heart disease 5) Active infection excluding hepatitis B or C viral infection 6) Active concomitant malignancy 7) Severe mental disorder 8) Severe allergic reaction to drug 9) Severe complication 10) Pregnant and lactating females; females of childbearing age unless using effective contraception

Related Information

• Primary Sponsor: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare