A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202

Cancer Chemotherapy and Pharmacology

Volumn 68, Issue 6, 2011, Pages 1595-1602

  Iqbal, Syma ^a   Rankin, Cathryn ^b   Lenz, Heinz Josef ^a   Gold, Philip J ^c   Ahmad, Syed A ^d   El Khoueiry, Anthony B ^a   Messino, Michael J ^e   Holcombe, Randall F ^f   Blanke, Charles D ^g  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER   (United States)

^c SWEDISH MEDICAL CENTER   (United States)

^d UNIVERSITY OF CINCINNATI   (United States)

^e Southeast Cancer Control Consortium   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g BRITISH COLUMBIA CANCER AGENCY   (Canada)

Author keywords

Capecitabine; Cholangiocarcinoma; Clinical trial; Gallbladder; Gemcitabine

Indexed keywords

ALKALINE PHOSPHATASE; CAPECITABINE; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BILE DUCT CARCINOMA; BLEEDING; BLOOD TOXICITY; BONE MARROW TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER PATIENT; CANCER SURVIVAL; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EMBOLISM; EYE TOXICITY; FATIGUE; FEMALE; GALLBLADDER CANCER; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HEART ARRHYTHMIA; HEPATOBILIARY DISEASE; HUMAN; HUMAN CELL; HUMAN TISSUE; INFECTION; LEUKOPENIA; LIVER FUNCTION TEST; LIVER TOXICITY; LUNG TOXICITY; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; METASTASIS POTENTIAL; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; MYALGIA; NAUSEA; NEPHROTOXICITY; NEUROTOXICITY; NEUTROPENIA; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PANCREAS DISEASE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROBABILITY; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN TOXICITY; SOFT TISSUE DISEASE; SURVIVAL TIME; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT RESPONSE; UROGENITAL TRACT DISEASE; VASCULAR DISEASE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BILE DUCT NEOPLASMS; BILE DUCTS, INTRAHEPATIC; CHOLANGIOCARCINOMA; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; GALLBLADDER NEOPLASMS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; THYMIDYLATE SYNTHASE;

EID: 82455168012     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-011-1657-1     Document Type: Article

References (23)

1. American Cancer Society (2010). Cancer facts & figures. American Cancer Society, Atlanta
2. Serra I, Calvo A, Baez S et al (1996) Risk factors for gallbladder cancer. An international collaborative case-control study. Cancer 78:1515-1517 (Pubitemid 26317875)
3. G Falkson JM MacIntyre CG Moertel 1984 Eastern Cooperative Oncology Group experience with chemotherapy for inoperable gallbladder and bile duct cancer Cancer 54 965 969 6235908 10.1002/1097-0142(19840915)54:6<965::AID- CNCR2820540603>3.0.CO;2-X 1:STN:280:DyaL2c3ot1ahtA%3D%3D (Pubitemid 14069807)
4. Takada T, Kato H, Matsushiro T et al (1996) Prospective randomized trial comparing 1/2 FAM (5-fluorouracil (5-FU) + adriamycin + mitomycin C) versus palliative therapy for the treatment of unresectable pancreatic and biliary tract carcinomas (the 2nd trial in non-resectable patients). Japanese Study Group of Surgical Adjuvant Therapy for Carcinomas of the Pancreas and Biliary Tract. Gan To Kagaku Ryoho 23:707-714 (Pubitemid 26190081)
5. M Kajanti S Pyrhonen 1994 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 8192106 10.1097/00000421-199406000-00008 1:STN:280:DyaK2c3kvFKgtg%3D%3D (Pubitemid 24160612)
6. Patt YZ, Jones DV Jr, Hoque A et al (1996) Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. J Clin Oncol 14:2311-2315 (Pubitemid 26264882)
7. Sanz-Altamira PM, Ferrante K, Jenkins RL et al (1998) A phase II trial of 5-fluorouracil, leucovorin, and carboplatin in patients with unresectable biliary tree carcinoma. Cancer 82:2321-2325 (Pubitemid 28283437)
8. F Verderame P Mandina F Abruzzo, et al. 2000 Biliary tract cancer: our experience with gemcitabine treatment Anticancer Drugs 11 707 708 11129732 10.1097/00001813-200010000-00006 1:CAS:528:DC%2BD3cXovFCitrs%3D
9. MP Castro 1998 Efficacy of gemcitabine in the treatment of patients with gallbladder carcinoma: a case report Cancer 82 639 641 9477094 10.1002/(SICI)1097-0142(19980215)82:4<639::AID-CNCR4>3.0.CO;2-G 1:STN:280:DyaK1c7jsF2lsw%3D%3D (Pubitemid 28090273)
10. Eng C, Ramanathan RK, Wong MK et al (2004) A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma. Am J Clin Oncol 27:565-569 (Pubitemid 39603269)
11. Valle J, Wasan H, Palmer DH et al (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362:1273-1281
12. F Eckel RM Schmid 2007 Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials Br J Cancer 96 896 902 17325704 10.1038/sj.bjc.6603648 1:CAS:528:DC%2BD2sXjt1SrsLw%3D (Pubitemid 46452283)
13. Braakhuis BJ, Ruiz van Haperen VW, Boven E et al (1995) Schedule-dependent antitumor effect of gemcitabine in in vivo model system. Semin Oncol 22:42-46
14. M Tempero W Plunkett V Ruiz Van Haperen, et al. 2003 Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma J Clin Oncol 21 3402 3408 12885837 10.1200/JCO.2003.09.140 1:CAS:528:DC%2BD2cXpsVKjtLs%3D (Pubitemid 46594072)
15. MV Mandola J Stoehlmacher W Zhang, et al. 2004 A 6 bp polymorphism in the thymidylate synthase gene causes message instability and is associated with decreased intratumoral TS mRNA levels Pharmacogenetics 14 319 327 15115918 10.1097/00008571-200405000-00007 1:CAS:528:DC%2BD2cXltVartrw%3D (Pubitemid 38638919)
16. Lurje G, Zhang W, Yang D et al (2008) Thymidylate synthase haplotype is associated with tumor recurrence in stage II and stage III colon cancer. Pharmacogenet Genomics 18:161-168
17. RP Riechelmann CA Townsley SN Chin, et al. 2007 Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer Cancer 110 1307 1312 17628484 10.1002/cncr.22902 1:CAS:528:DC%2BD2sXhtFCgtr%2FO (Pubitemid 47435603)
18. JY Cho YH Paik YS Chang, et al. 2005 Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma Cancer 104 2753 2758 16294346 10.1002/cncr.21591 1:CAS:528:DC%2BD28XptlSktQ%3D%3D (Pubitemid 41798285)
19. RV Iyer J Gibbs B Kuvshinoff, et al. 2007 A phase II study of gemcitabine and capecitabine in advanced cholangiocarcinoma and carcinoma of the gallbladder: a single-institution prospective study Ann Surg Oncol 14 3202 3209 17705089 10.1245/s10434-007-9539-9 (Pubitemid 47594289)
20. Santini D, Vincenzi B, Vasile E et al (2009) Fixed dose rate (FDR) gemcitabine (G) and capecitabine (C) in patients with metastatic biliary tract cancer (BTC): final results of phase II trial. Abstract # e15510. Proceedings of the American Society of Clinical Oncology
21. ST Kim JO Park J Lee, et al. 2006 A phase II study of gemcitabine and cisplatin in advanced biliary tract cancer Cancer 106 1339 1346 16475213 10.1002/cncr.21741 1:CAS:528:DC%2BD28XjtVCrsbo%3D (Pubitemid 43363912)
22. PK Julka T Puri GK Rath 2006 A phase II study of gemcitabine and carboplatin combination chemotherapy in gallbladder carcinoma Hepatobiliary Pancreat Dis Int 5 110 114 16481295 1:CAS:528:DC%2BD28XisF2ru7o%3D
23. André T, Reyes-Vidal JM, Fartoux L et al (2006) An international multicenter phase II trial of gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer. J Clin Oncol. ASCO annual meeting proceedings part I, vol 24, no. 18S (June 20 Supplement), p 4135