A phase I and II study of 2-weekly irinotecan with capecitabine in advanced gastroesophageal adenocarcinoma

British Journal of Cancer

Volumn 94, Issue 9, 2006, Pages 1281-1286

  Burge, M E ^a   Smith, D ^b   Topham, C ^c   Jackson, D P ^a   Anthoney, D A ^a   Halstead, F ^a   Seymour, M T ^a  

^a UNIVERSITY OF LEEDS   (United Kingdom)

^b CLATTERBRIDGE HOSPITAL   (United Kingdom)

^c ROYAL SURREY COUNTY HOSPITAL   (United Kingdom)

Author keywords

Capecitabine; Esophageal cancer; Gastric cancer; Irinotecan

Indexed keywords

CAPECITABINE; IRINOTECAN;

ABDOMINAL PAIN; ADENOCARCINOMA; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ATAXIA; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DYSPEPSIA; ESOPHAGEAL ADENOCARCINOMA; FEMALE; FEVER; HICCUP; HUMAN; INFECTION; LETHARGY; LOWER ESOPHAGUS SPHINCTER; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; NEUROPATHY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SKIN TOXICITY; STOMACH ADENOCARCINOMA; VOMITING;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; ESOPHAGEAL NEOPLASMS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; STOMACH NEOPLASMS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33646496600     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603084     Document Type: Article

References (29)

1. Assersohn L, Norman AR, Chong G, Brown G, Ross PJ, Costello C, Higgins L, Oates J, Cunningham D (2005) Phase II trial evaluating capecitabine and irinotecan (Capelri) in patients (pts) with esophago-gastric (E-G) carcinoma having progressed or relapsed within 3 months of platinum-based chemotherapy. Proc Am Soc Clin Oncol (abstr 4170)
2. Bajetta E, Di Bartolomeo M, Mariani L, Cassata A, Artale S, Frustaci S, Pinotti G, Bonetti A, Carreca I, Biasco G, Bonaglia L, Marini G, Iannelli A, Cortinovis D, Ferrario E, Beretta E, Lambiase A, Buzzoni R (2004) Randomized multicenter phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer 100: 279-287
3. Borner MM, Bernhard J, Dietrich D, Popescu R, Wernli M, Saletti P, Rauch D, Herrmann R, Koeberle D, Honegger H, Brauchli P, Lanz D, Roth AD (2005) A randomized phase II trial of capecitabine and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity. Ann Oncol 16: 282-288
4. Bouché O, Raoul JL, Bonnetain F, Giovannini M, Etienne PL, Lledo G, Arsene D, Paitel JF, Guerin-Meyer V, Mitry E, Buecher B, Kaminsky MC, Seitz JF, Rougier P, Bedenne L, Milan C (2004) Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Fédération Francophone de Cancérologie Digestive Group Study - FFCD 9803. J Clin Oncol 22: 4319-4328
5. Brown LM, Devesa SS (2002) Epidemiologic trends in oesophageal and gastric cancer in the US. Surg Oncol Clin N Am 11: 235-256
6. Cunningham D, Allum WH, Stenning SP, Weeden S (2005) Perioperative chemotherapy in operable gastric and lower oesophageal cancer: final results of a randomised, controlled trial (the MAGIC trial, ISRCTN 93793971). Proc Am Soc Clin Oncol (abstr 4001)
7. Dank M, Zaluski J, Barone C, Valvere V, Peschel C, Wenczl M, Goker E, Risse M, Awad L, Bugat R (2005) Randomized phase 3 trial of irinotecan (CPT-11)+5FU/folinic acid (FA) vs CDDP+5FU in 1st-line advanced gastric cancer patients. Proc Am Soc Clin Oncol (abstr 4003)
8. Delord JP, Pierga JY, Dieras V, Bertheault-Cvitkovic F, Turpin FL, Lokiec F, Lochon I, Chatelut E, Canal P, Guimbaud R, Mery-Mignard D, Cornen X, Mouri Z, Bugat R (2005) A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours. Br J Cancer 92: 820-826
9. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Ivenson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355: 1041-1047
10. Globocan (2002) www-dep.iacr.fr/globocan
11. Hapke G, Cao S, Rutsum Y (2001) Enhanced antitumour activity of xeloda by irinotecan in nude mice bearing human A253 and FaDu head and neck xenografts. Proc Am Assoc Cancer Res 42: 86 (abstr 464)
12. Hong YS, Song SY, Lee SI, Chung HC, Choi SH, Noh SH, Park JN, Han JY, Kang JH, Lee KS, Cho JY (2004) A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. Ann Oncol 15: 1344-1347
13. Kohne C, de Greve J, Bokemeyer C, Lang I, Vergauwe P, Braumann D, Debois M, Meulemans B, Therasse P, van Cutsem E (2005) Capecitabine plus irinotecan versus 5-FU/FA/irinotecan+/-celecoxib in first line + treatment of metastatic colorectal cancer. Safety results of the prospective multicenter EORTC phase III study 40015. Proc Am Soc Clin Oncol (abstr 3525)
14. Kohne CH, Catane R, Klein B, Ducreux M, Thuss-Patience P, Niederle N, Gips M, Presusser P, Knuth A, Clemens M, Bugat R, Figer I, Shani A, Fages B, Di Betta D, Jacques C, Wilke HJ (2003) Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multi-centric trial. Br J Cancer 89: 997-1001
15. Lorenzen S, Duyster J, Lersch C, von Delius S, Hennig M, Bredenkamp R, Peschel C, Lordick F (2005) Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial. Br J Cancer 92: 2129-2133
16. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda I, Ishitsuka H (1998) Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34: 1274-1281
17. Murad AM, Santiago FF, Petroianu A, Rocha PR, Rodrigues MA, Rausch M (1993) Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer 72: 37-41
18. Neave HR (1981) Elementary Statistical Tables. London: Unwin Hyman Ltd Publ
19. Pozzo C, Barone C, Szanto J, Padi E, Peschel C, Bukki J, Gorbunova V, Valvere V, Zaluski J, Biakhov M, Zuber E, Jacques C, Bugat R (2004) Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: results of a randomized phase II study. Ann Oncol 15: 1773-1781
20. Rea DW, Nortier JW, Ten Bokkel Huinink WW, Falk S, Richel DJ, Maughan T, Groenewegen G, Smit JM, Steven N, Bakker JM, Semiond D, Kerr DJ, Punt CJ (2005) A phase I/II and pharmacokinetic study of irinotecan in combination with capecitabine as first-line therapy for advanced colorectal cancer. Ann Oncol 16: 1123-1132
21. Scheithauer W, Kornek G, Raderer M, Schull B, Schmid k, Kovats E, Schneeweiss B, Lang F, Lenauer A, Depisch D (2003) Randomized multicenter phase II trial of two different schedules of capecitabine plus oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 21: 1307-1312
22. Seymour MT (2005) Fluorouracil, oxaliplatin and CPT-11 (irinotecan), use and sequencing (MRC FOCUS): a 2135-patient randomized trial in advanced colorectal cancer (ACRC). Proc Am Soc Clin Oncol (abstr 3518)
23. Sumpter K, Harper-Wynne C, Cunningham D, Rao S, Tebbutt N, Norman AR, Ward C, Iveson T, Nicolson M, Hickish T, Hill M, Oates J (2005) Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF. Br J Cancer 92: 1976-1983
24. Tewes M, Schleucher N, Achterrath W, Wilke HJ, Frings S, Seeber S, Harstrick A, Rustum YM, Vanhoefer U (2003) Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study. Ann Oncol 14: 1442-1448
25. Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22: 229-237
26. Twelves C, Wong A, Nowacki MP, Twelves C, Wong A, Nowacki MP, Abt M, Burris III H, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kroning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schuller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W (2005) Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 352: 2696-2704
27. Van Cutsem E, Hoff PM, Harper P, Bukowski RM, Cunningham D, Dufour P, Graeven U, Lokich J, Madajewicz S, Maroun JA, Mashall JL, Mitchell EP, Perez-Manga G, Rougier P, Schmiegel W, Schoelmerich J, Sobrero A, Schilsky RL (2004) Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer 90: 1190-1197
28. Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M (1997) Randomised trial comparing epirubicin, cisplatin and fluorouracil versus fluorouracil, doxorubicin and methotrexate in advanced oesophagogastric cancer. J Clin Oncol 15: 261-267
29. Wohrer S, Raderer M, Hejna M (2004) Palliative chemotherapy for advanced gastric cancer. Ann Oncol 15: 1585-1595