Phase I/II study of hepatic arterial infusion chemotherapy with gemcitabine in patients with unresectable intrahepatic cholangiocarcinoma (JIVROSG-0301)

American Journal of Clinical Oncology: Cancer Clinical Trials

Volumn 34, Issue 1, 2011, Pages 58-62

  Inaba, Yoshitaka ^a   Arai, Yasuaki ^b   Yamaura, Hidekazu ^a   Sato, Yozo ^a   Najima, Mina ^a   Aramaki, Takeshi ^c   Sone, Miyuki ^d   Kumada, Takashi ^e   Tanigawa, Noboru ^f   Anai, Hiroshi ^g   Yoshioka, Tetsuya ^h   Ikeda, Masafumi ⁱ  

^a AICHI CANCER CENTER HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c SHIZUOKA CANCER CENTER   (Japan)

^d IWATE MEDICAL UNIVERSITY   (Japan)

^e OGAKI MUNICIPAL HOSPITAL   (Japan)

^f KANSAI MEDICAL UNIVERSITY   (Japan)

^g NARA MEDICAL UNIVERSITY   (Japan)

^h NARA MEDICAL UNIVERSITY HOSPITAL   (Japan)

ⁱ NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

Author keywords

clinical trial; gemcitabine; hepatic arterial infusion; intrahepatic cholangiocarcinoma; phase I II study

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; GAMMA GLUTAMYLTRANSFERASE; GEMCITABINE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; DIARRHEA; DOSE RESPONSE; DRUG DOSE INCREASE; DRUG EFFECT; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG INFUSION; DRUG SAFETY; FATIGUE; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEPATIC ARTERY; HEPATOBILIARY SYSTEM CANCER; HUMAN; HYPERKALEMIA; HYPOALBUMINEMIA; HYPONATREMIA; INOPERABLE CANCER; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PORTAL VEIN THROMBOSIS; RECOMMENDED DRUG DOSE; SIDE EFFECT; STOMATITIS; THROMBOCYTE; THROMBOCYTOPENIA; TREATMENT RESPONSE; UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; BILE DUCT NEOPLASMS; BILE DUCTS, INTRAHEPATIC; CHOLANGIOCARCINOMA; DEOXYCYTIDINE; FEMALE; HEPATIC ARTERY; HUMANS; INFUSIONS, INTRA-ARTERIAL; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 79951638443     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e3181d2709a     Document Type: Article

References (23)

1. Nakamura Y, Hoso M, Terada T. Clinical and pathologic features of chol-angiocarcinoma. In: Okuda K, Tabor E, eds. Liver Cancer. New York, NY: Churchill Livingstone; 1997:313-335.
2. Olnes MJ, Erlich R. A review and update on cholangiocarcinoma. Oncology. 2004;66:167-179. (Pubitemid 38813042)
3. Khan SA, Davidson BR, Goldin R, et al. Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document. Gut. 2002;51(suppl 6): VI1-VI9. (Pubitemid 35216840)
4. Verslype C, Prenen H, Van Cutsem E. The role of chemotherapy in biliary tract carcinoma. HPB (Oxford). 2008;10:164-167. (Pubitemid 352016240)
5. Thongprasert S. The role of chemotherapy in cholangiocarcinoma. Ann Oncol. 2005;16(suppl 2):ii93-ii96. (Pubitemid 40908942)
6. Dingle BH, Rumble RB, Brouwers MC. The role of gemcitabine in the treatment of cholangiocarcinoma and gallbladder cancer: a systematic review. Can J Gastroenterol. 2005;19:711-716. (Pubitemid 43125123)
7. Arai Y, Inaba Y, Takeuchi Y, et al. Interventional techniques for arterial infusion chemotherapy. In: Casterneda-Zuniga WR, ed. Interventional Radiology. 3rd ed. Baltimore, MD: Williams and Wilkins; 1997:192-205.
8. Yamagami T, Iida S, Kato T, et al. Using N-butyl cyanoacrylate and the fixed-catheter-tip technique in percutaneous implantation of a port-catheter system in patients undergoing repeated hepatic arterial chemotherapy. Am J Roentgenol. 2002;179:1611-1617. (Pubitemid 35386668)
9. Tanaka T, Arai Y, Inaba Y, et al. Radiologic placement of side-hole catheter with tip fixation for hepatic arterial infusion chemotherapy. J Vasc Interv Radiol. 2003;14:63-68. (Pubitemid 36134075)
10. Seki H, Kimura M, Yoshimura N, et al. Hepatic arterial infusion chemotherapy using percutaneous catheter placement with an implantable port: assessment of factors affecting patency of the hepatic artery. Clin Radiol. 1999;54: 221-227. (Pubitemid 29178862)
11. Urego M, Flickinger JC, Carr BI. Radiotherapy and multimodality management of cholangiocarcinoma. Int JRadiat Oncol Biol Phys. 1999;44:121-126. (Pubitemid 29186198)
12. Todoroki T. Chemotherapy for bile duct carcinoma in the light of adjuvant chemotherapy to surgery. Hepatogastroenterology. 2000;47:644-649. (Pubitemid 30417267)
13. Tanaka N, Yamakado K, Nakatsuka A, et al. Arterial chemoinfusion therapy through an implanted port system for patients with unresectable intrahepatic cholangiocarcinoma-initial experience. Eur J Radiol. 2002;41:42-48. (Pubitemid 34002989)
14. Burris HA III, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15:2403-2413. (Pubitemid 27251144)
15. Okada S, Ueno H, Okusaka T, et al. Phase I trial of gemcitabine in patients with advanced pancreatic cancer. Jpn J Clin Oncol. 2001;31:7-12. (Pubitemid 32236880)
16. Kubicka S, Rudolph KL, Tietze MK, et al. Phase II study of systemic gemcitabine chemotherapy for advanced unresectable hepatobiliary carcinomas. Hepatogastroenterology. 2001;48:783-789. (Pubitemid 32619681)
17. Tsujino T, Isayama H, Ito Y, et al. Hepatic arterial infusion chemotherapy with gemcitabine for patients with intrahepatic cholangiocarcinoma [in Japanese]. In: Proceedings of Japanese Society of Implantable Port Assisted Regional Treatment. 2003;25:39. Abstract.
18. Harmantas A, Rotstein LE, Langer B. Regional versus systemic chemotherapy in the treatment of colorectal carcinoma metastatic to the liver. Is there a survival difference? Meta-analysis of the published literature. Cancer. 1996; 78:1639-1645 (Pubitemid 26330889)
19. Meta-Analysis Group in Cancer. Reappraisal of hepatic arterial infusion in the treatment of nonresectable liver metastases from colorectal cancer. Metaanalysis group in cancer. J Natl Cancer Inst. 1996;88:252-258.
20. Arai Y, Sone Y, Inaba Y, et al. Hepatic arterial infusion chemotherapy for liver metastases from breast cancer. Cancer Chemother Pharmacol. 1994; 33(suppl):S142-S144. (Pubitemid 24147985)
21. Llovet JM, Real MI, Montana X, et al. Arterial embolization or chemoem-bolization versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomized controlled trial. Lancet. 2002;359:1734-1739. (Pubitemid 34607087)
22. Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: chemoembolization improves survival. Hepatology. 2003;37:429-442. (Pubitemid 36152543)
23. Okusaka T, Ishii H, Funakoshi A, et al. Phase II study of single-agent gemcitabine in patients with advanced biliary tract cancer. Cancer Chemother Pharmacol. 2006;57:647-653. (Pubitemid 43237850)