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Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC

Information source: Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Hepatocellular Carcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Neoplasms

Intervention: Sorafenib with Low-dose FP (Drug); Sorafenib (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ministry of Health, Labour and Welfare, Japan

Official(s) and/or principal investigator(s):
Masatoshi Kudo, Professor, Study Chair, Affiliation: Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology

Overall contact:
Masatoshi Kudo, Professor, Phone: +81-72-366-0221, Ext: 3149, Email: m-kudo@med.kindai.ac.jp

Summary

The purpose of this study is to evaluate the efficacy of sorafenib in combination with low dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma.

Clinical Details

Official title: Randomized Controlled Trial Comparing Efficacy of Sorafenib Versus Sorafenib In Combination With Low Dose Cisplatin /Fluorouracil Hepatic Arterial InfUSion Chemotherapy in Patients With Advanced Hepatocellular Carcinoma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall survival

Secondary outcome:

Time to progression

Progression Free Survival

Change of tumor marker

Biomarker predicting the efficacy

Detailed description: Sorafenib with Low-dose FP Group Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system. Sorafenib Group Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 20 Years and older. 2. Life expectancy of at least 12 weeks at the pre-treatment evaluation. 3. Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography. 4. Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization. 5. ECOG Performance status of 0 or 1. 6. Cirrhotic status of Child-Pugh score ≤ 7. 7. 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

- Total serum bilirubin ≤ 2 mg/dl

- AST(SGOT) and ALT(SGPT) ≤ 6 × upper limit of normal

- Serum creatinine ≤ 1. 5 × upper limit of normal

- Amylase ≤ 2 × upper limit of normal

8. Written Informed Consent must be obtained. Exclusion Criteria: 1. 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 2. Renal failure 3. 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

4. Active clinically serious infections except for HBV and HCV 5. Active chicken pox. 6. Auditory disorder. 7. Known history of HIV infection. 8. Known metastatic or meningeal tumors. 9. Extrahepatic tumor spread which affects patient's prognosis 10. History of seizure disorder. 11. Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry. 12. Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization. 13. 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

14. Patients unable to swallow oral medications. 15. Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics. 16. Medication that may affect to the absorption of drug or pharmacokinetics. 17. Any disease or disorder that may affect the evaluation of study drug. 18. Entry to the other clinical trial within 4 weeks prior to entry to this study. 19. Pregnant or breast-feeding patients. 20. Known allergy to the investigational agent or any agent given in association with this trial. 21. 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. 22. Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

Locations and Contacts

Masatoshi Kudo, Professor, Phone: +81-72-366-0221, Ext: 3149, Email: m-kudo@med.kindai.ac.jp

Chiba University Hospital, Chiba 260-8677, Japan; Recruiting
Fumihiko Kanai, Dr.
Fumihiko Kanai, Dr., Principal Investigator

Gifu Municipal Hospital, Gifu 500-8513, Japan; Recruiting
Eiichi Tomita, Dr.
Eiichi Tomita, Dr., Principal Investigator

Hiroshima City Hospital, Hiroshima 730-8518, Japan; Recruiting
Yoshiyuki Kobayashi, Dr.
Yoshiyuki Kobayashi, Dr., Principal Investigator

Hiroshima University Hospital, Hiroshima 734-8551, Japan; Recruiting
Hiroshi Aikata, Dr.
Hiroshi Aikata, Dr., Principal Investigator

Kumamoto University Hospital, Kumamoto 860-8556, Japan; Recruiting
Yutaka Sasaki, Professor
Yutaka Sasaki, Professor, Principal Investigator

Kyoto University Hospital, Kyoto 606-8507, Japan; Recruiting
Etsuro Hatano, Professor
Etsuro Hatano, Professor, Principal Investigator

Center for Gastroenterological and Hepatological Diseases, Miyazaki 880-0003, Japan; Recruiting
Hidemori Sakamoto, Dr.
Hidemori Sakamoto, Dr., Principal Investigator

Niigata University Medical and Dental Hospital, Niigata 951-8520, Japan; Recruiting
Kouhei Akazawa
Kouhei Akazawa, Principal Investigator

Saiseikai Niigata Dai-ni Hospital, Niigata 950-1104, Japan; Recruiting
Toru Ishikawa, Dr.
Toru Ishikawa, Dr., Principal Investigator

Okayama University Hospital, Okayama 700-8558, Japan; Recruiting
Kazuhide Yamamoto, Professor
Kazuhide Yamamoto, Professor, Principal Investigator

Osaka Red Cross Hospital, Osaka 543-8555, Japan; Recruiting
Ikuo Osaki, Dr.
Ikuo Osaki, Dr., Principal Investigator

The University of Tokushima Faculty of Medicine, Tokushima 770-8503, Japan; Recruiting
Tetsuji Takayama, Dr.
Tetsuji Takayama, Dr., Principal Investigator

Kyoundo Hospital, Tokyo 101-0062, Japan; Recruiting
Shuntaro Obi, Dr.
Shuntaro Obi, Dr., Principal Investigator

National Cancer Center Hospital, Tokyo 104-0045, Japan; Recruiting
Takushi Okusaka, Dr.
Takushi Okusaka, Dr., Principal Investigator

National Cancer Center Hospital East, Kashiwa, Chiba 277-8577, Japan; Recruiting
Masafumi Ikeda, Dr.
Masafumi Ikeda, Dr., Principal Investigator

Kurume University Medical Center, Kurume, Fukuoka 839-0863, Japan; Recruiting
Masatoshi Tanaka, Professor
Masatoshi Tanaka, Professor, Principal Investigator

Ogaki Municipal Hospital, Ogaki, Gifu 503-8502, Japan; Recruiting
Takashi Kumada, Dr
Takashi Kumada, Dr., Principal Investigator

Sapporo Medical University, Sapporo, Hokkaido 060-8556, Japan; Recruiting
Junji Kato, Dr.
Junji Kato, Dr., Principal Investigator

Sapporo-Kosei General Hospital, Sapporo, Hokkaido 060-8556, Japan; Recruiting
Takumi Ohmura, Dr.
Takumi Ohmura, Dr., Principal Investigator

Japanese Red Cross Takamatsu Hospital, Takamatsu, Kagawa 760-0017, Japan; Recruiting
Chikara Ogawa, Dr.
Chikara Ogawa, Dr., Principal Investigator

Mie University Hospital, Tsu, Mie 514-8507, Japan; Recruiting
Katsuya Shiraki, Dr.
Katsuya Shiraki, Dr., Principal Investigator

National Hospital Organization Nagasaki Medical Center, Ohmura, Nagasaki 856-8562, Japan; Recruiting
Hiromi Ishibashi, Dr.
Hiromi Ishibashi, Dr., Principal Investigator

Kawasaki Medical School Hospital, Kurashiki, Okayama 701-0192, Japan; Recruiting
Keisuke Hino, Dr.
Keisuke Hino, Dr., Principal Investigator

Ikeda Municipal Hospital, Ikeda, Osaka 563-8510, Japan; Recruiting
Yasuharu Imai, Dr.
Yasuharu Imai, Dr., Principal Investigator

Kinki University Hospital, Osaka-Sayama, Osaka 589-8511, Japan; Recruiting
Masatoshi Kudo, Professor, Phone: +81-72-366-0221, Ext: 3149, Email: m-kudo@med.kindai.ac.jp
Kazuomi Ueshima, Dr., Phone: +81-72-366-0221, Ext: 3525, Email: kaz-ues@med.kindai.ac.jp
Masatoshi Kudo, Professor, Principal Investigator
Kazuomi Ueshima, Dr., Sub-Investigator
Kazuto Nishio, Professor, Principal Investigator

Osaka University Hospital, Suita, Osaka 565-0871, Japan; Recruiting
Hiroaki Nagano, Professor
Hiroaki Nagano, Professor, Principal Investigator

Kyorin University Hospital, Mitaka, Tokyo 181-8611, Japan; Recruiting
Junji Furuse, Professor
Junji Furuse, Professor, Principal Investigator

Musashino Red Cross Hospital, Musashino, Tokyo 180-8610, Japan; Recruiting
Namiki Izumi, Dr.
Namiki Izumi, Dr., Principal Investigator

Juntendo University Nerima Hospital, Nerima, Tokyo 177-0033, Japan; Recruiting
Shigehiro Kokubu, Dr.
Shigehiro Kokubu, Dr., Principal Investigator

Yamaguchi University Hospital, Ube, Yamaguchi 755-8505, Japan; Recruiting
Isao Sakaida, Prof
Isao Sakaida, Professor, Principal Investigator

Additional Information

Starting date: October 2010
Last updated: June 14, 2011

Page last updated: August 23, 2015

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