Combining gemcitabine and capecitabine in patients with advanced biliary cancer: A phase II trial

Journal of Clinical Oncology

Volumn 23, Issue 10, 2005, Pages 2332-2338

  Knox, Jennifer J ^a   Hedley, David ^a   Oza, Amit ^a   Feld, Ron ^a   Siu, Lillian L ^a   Chen, Eric ^a   Nematollahi, Mahsan ^a   Pond, Gregory R ^a   Zhang, Jessica ^a   Moore, Malcolm J ^a  

^a UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; GEMCITABINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE;

ADENOCARCINOMA; ADULT; ADVANCED CANCER; AGED; ARTICLE; BILE DUCT CANCER; BILE DUCT CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GALLBLADDER CANCER; HAND FOOT SYNDROME; HUMAN; INFECTION; LIVER TOXICITY; MALE; METASTASIS; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT RESPONSE; VOMITING; DISEASE COURSE; GALLBLADDER TUMOR; INTRAHEPATIC CHOLESTASIS; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; OBSTRUCTIVE JAUNDICE; ORAL DRUG ADMINISTRATION; PATHOLOGY; PROGNOSIS; SURVIVAL;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHOLESTASIS, EXTRAHEPATIC; CHOLESTASIS, INTRAHEPATIC; DEOXYCYTIDINE; DISEASE PROGRESSION; FEMALE; GALLBLADDER NEOPLASMS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; PROGNOSIS; SURVIVAL ANALYSIS;

EID: 20244371852     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.51.008     Document Type: Article

References (35)

1. Oertli D, Herzog U, Tondelli P: Primary carcinoma of the gallbladder: Operative experience during a 16-year period. Eur J Surg 159:415-420, 1993
2. Alexander F, Rossi RL, O'Bryan M, et al: Biliary carcinoma: A review of 109 cases. Am J Surg 147:503-509, 1984
3. Wade TP, Prasad CN, Virgo KS, et al: Experience with distal bile duct cancers in US veterans affairs hospitals: 1987-1991. J Surg Oncol 64:242-245, 1997
4. De Groen PC, Gores GJ, La Russo NF, et al: Biliary tract cancers. N Engl J Med 341:1368-1378, 1999
5. Falkson G, Macintyre JM, Moertel CG: Eastern Cooperative Oncology Group experience with chemotherapy for inoperable gallbladder and bile duct cancer. Cancer 54:965-969, 1984
6. Takada T, Kato H, Matsushiro T, et al: Combination of 5-fluorouracil, doxorubicin and mitomycin C with 5-fluorouracil alone in the treatment of pancreatic-biliary carcinomas. Oncology 51:396-400, 1994
7. Kajanti M, Pyrhonen S: Epirubicin-sequential methotrexate-5-fluorouracil- leucovorin treatment in advanced cancer of the extrahepatic biliary system: A phase II study. Am J Clin Oncol 17:223-226, 1994
8. Glimelius B, Hoffman K, Sjoden PO: Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol 7:593-600, 1996
9. Gallardo JO, Rubio B, Fodor M, et al: A phase II study of gemcitabine in gallbladder carcinoma. Ann Oncol 12:1403-1406, 2001
10. Dragovich T, Ramanathan R, Remick S, et al: Phase II trial of a weekly 150-minute gemcitabine infusion in patients with biliary tree carcinomas. Proc Am Soc Clin Oncol 19:264a, 2000 (abstr 1159)
11. Kubicka S, Rudolph KL, Tietze MK, et al: A phase II study of gemcitabine chemotherapy for advanced unresectable hepatobiliary carcinomas. Hepatogastroenterology 48:783-789, 2001
12. Penz M, Kornek GV, Raderer M, et al: Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer. Ann Oncol 12:183-186, 2001
13. Reyes-Vidal J, Gallardo J, Yanez E, et al: Gemcitabine and cisplatin in the treatment of patients with unresectable or metastatic gallbladder cancer. Results of the phase II Gocchi study 2000-13. Proc Am Soc Clin Oncol 22:273, 2003 (abstr 1095)
14. Dorval DC, Sekhon JS, Gupta SK, et al: A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer. Br J Cancer 90:1516-1520, 2004
15. Raderer M, Hejna MH, Valencak JB, et al: Two consecutive phase II studies of 5-FU/leucovorin/mitomycin and of gemcitabine in patients with advanced biliary cancer. Oncology 56:177-180, 1999
16. Gebbia V, Giuliani F, Maiello E, et al: Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: Results of a multicenter phase II study. J Clin Oncol 19:4089-4091, 2001
17. Hsu C, Shen Y-C, Yang C-H, et al: Weekly gemcitabine plus 24-h infusion of high-dose 5-fluorouracil/leucovorin for locally advanced or metastatic carcinoma of the biliary tract. Br J Cancer 90:1715-1719, 2004
18. Lozano RD, Patt YZ, MM Hassan, et al: Oral capecitabine (Xeloda) for the treatment of hepatobiliary cancers (hepatocellular carcinoma, cholangiocarcinoma and gallbladder cancer). Proc Am Soc Clin Oncol 19:264a, 2000 (abstr 1025)
19. Kornek GV, Schuell B, Laengle F, et al: Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: A randomized phase II trial. Ann Oncol 15:478-483, 2004
20. Nehls O, Oettle H, Hartmann J-T, et al: Multicenter phase II trial of oxaliplatin plus capecitabine (XELOX) in advanced biliary system adenocarcinomas (study CCC/GBC-01). Proc Am Soc Clin Oncol 22:280, 2003 (abstr 1126)
21. Taïeb J, Mitry E, Boige V, et al: Optimization of 5-fluorouracil (5-FU)/cisplatin combination chemotherapy with a new schedule of leucovorin, 5-FU and cisplatin (LV5FU2-P regimen) in patients with biliary tract carcinoma. Ann Oncol 13:1192-1196, 2002
22. Sanz-Altamira P, Ferrante, Jenkins R: A phase II trial of 5-FU leucovorin and carboplatin in patients with unresectable biliary tree carcinoma. Cancer 82:2321-2325, 1998
23. Mitry E, Van Cutsem E, Van Laethem JL, et al: A randomized phase II trial of weekly high dose 5-FU (HD-FU) with and without folinic acid (FA) and cisplatin (P) in patients with advanced biliary tract carcinoma: The EORTC 40955 trial. Proc Am Soc Clin Oncol 21:175a, 2002 (abstr 698)
24. Patt YZ, Hassan MM, Lozano RD, et al: Phase II trial of cisplatin, interferon alpha-2b, doxorubicin, and fluorouracil for biliary tract cancer. Clin Cancer Res 7:3375-3380, 2001
25. Rao S, Cunningham D, Hawkins R, et al: Phase III trial comparing epirubicin, cisplatin and 5-FU (ECF) versus 5FU, etoposide and leucovorin (FELV) in previously untreated patients with advanced biliary cancer. Proc European Cancer Conference 12:S17, 2003 (abstr 44)
26. Hidalgo M, Castellano D, Pas-Ares L, et al: Phase I-II study of gemcitabine and fluorouracil as a continuous infusion in patients with pancreatic cancer. J Clin Oncol 17:585-592, 1999
27. Hess V, Salzberg M, Borner M, et al: Combining capecitabine and gemcitabine in patients with advanced pancreatic carcinoma: A phase I/II trial. J Clin Oncol 21:66-68, 2003
28. Schulz L, Schalhorn W, Wilmanns W, et al: Synergistic interaction of gemcitabine and 5-fluorouracil in colon cancer cells. Proc Am Soc Clin Oncol 17:251a, 1998 (abstr 965)
29. Sawada N, Fujimoto-Ouchi K, Ishikawa T, et al: Antitumor activity of combination therapy with capecitabine plus vinorelbine, and capecitabine plus gemcitabine in human tumor xenograft models. Proc Am Assoc Cancer Res 43: 1088, 2002 (abstr 5388)
30. Knox JJ, Hedley D, Oza A, et al: Gemcitabine concurrent with continuous infusional 5-fluorouracil in advanced biliary cancers: A review of the Princess Margaret Hospital experience. Ann Oncol 15:770-774, 2004
31. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors (RECIST) guidelines. J Natl Cancer Inst 92:205-216, 2000
32. Kuhn R, Hribaschek A, Eichelmann K, et al: Outpatient therapy with gemcitabine and docetaxel for gallbladder, biliary, and cholangiocarcinomas. Invest New Drugs 20:351-356, 2002
33. André T, Tournigand C, Rosmorduc O, et al: Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: A GERCOR study. Ann Oncol 15:1339-1343, 2004
34. Greenlee RT, Hill-Harmon MB, Murray T, et al: Cancer statistics, 2001. CA Cancer J Clin 51:15-36, 2001
35. Philip PA, Mahoney M, Thomas J, et al: Phase II trial of erlotinib (OSI-774) in patients with hepatocellular or biliary cancer. Proc Am Soc Clin Oncol 23:318, 2004 (abstr 4025)