A review of the clinical experience with irinotecan (CPT-11)

American Journal of Therapeutics

Volumn 4, Issue 5-6, 1997, Pages 203-210

  Horowitz, Robert W ^a,b   Wadler, Scott ^a   Wiernik, Peter H ^a  

^a ALBERT EINSTEIN CANCER CENTER   (United States)

^b MONTEFIORE MEDICAL CENTER   (United States)

Author keywords

Cancer; Irinotecan (CPT 11); Review

Indexed keywords

IRINOTECAN;

CANCER CHEMOTHERAPY; CLINICAL TRIAL; DIGESTIVE SYSTEM CANCER; GYNECOLOGIC CANCER; HUMAN; LEUKEMIA; LUNG CANCER; LYMPHOMA; MALIGNANT NEOPLASTIC DISEASE; PRIORITY JOURNAL; REVIEW;

EID: 0030967535     PISSN: 10752765     EISSN: None     Source Type: Journal    
DOI: 10.1097/00045391-199705000-00007     Document Type: Review

References (62)

1. Wall ME, Wani MC, Cook CE, Palmer KH, McPhail HT, Sim GA: Plant antitumor agents. I. The isolation and structure of camptothecin, a novel alkaloidal leukemia and tumor inhibitor from Camptotheca acuminata. J Am Chem Soc 1966;88:3888-3890.
2. Wall ME, Ward MC: Camptothecin and taxol: discovery to clinic. Thirteenth Bruce F. Cain Memorial Award Lecture. Cancer Res 1995;55:753-760.
3. Hsiang YH, Lihou MG, Liu LF: Arrest of replication forks by drug-stabilized topoisomerase 1-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res 1989;49:5077-5082.
4. D'arpa P, Machlin PS, Ratrie H III, Rothfield NF, Cleveland DW, Earnshaw WC: cDNA cloning of human DNA topoisomerase I: catalytic activity of a 67.7 kD carboxyl-terminal fragment. Proc Natl Acad Sci U S A 1988;85: 2543-2547.
5. Juan CC, Hwang JL, Liu AA, Whang-Peng J, Knutsen T, Huebner K, Croce CM, Zhang H, Wang JC, Liu LF: Human DNA topoisomerase I is encoded by a single-copy gene that maps to chromosome 20q12-13.2. Proc Natl Acad Sci U S A 1988;85:8910-8913.
6. Wang JC: DNA topoisomerases. Annu Rev Biochem 1985;54:665-697.
7. Hwang J, Shyy S, Chen AY, Juan CC, Whang-Peng J: Studies of topoisomerase specific antitumour drugs in human lymphocytes using rabbit antisera against recombinant human topoisomerase II polypeptide. Cancer Res 1989;49:958-962.
8. Sinha BK: Topoisomerase Inhibitors: a review of their therapeutic potential in cancer. Drugs 1995;49:11-1995.
9. Giovanella BC, Stehlin JS, Wall ME, Wani MC, Nicholas AW, Liu LF, Silber R, Potmesil M: DNA topoisomerase-1 targeted chemotherapy of human colon cancer in xenographs. Science 1989;246:1046-1048.
10. Kaneda N, Nagata H, Furuta T, Yokokura T: Metabolism and pharmacokinetics of the camptothecin analogue CPT-11 in the mouse. Cancer Res 1990;50:1715-1720.
11. Kawato Y, Aonuma M, Hirota Y, Kuga H, Sato K: Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res 1991;51:4187-1191.
12. Takasuna K, Hagiwara T, Hirohashi M, Kato M, Nomura M, Nagai E, Yokoi T, Kamataki T: Involvement of β-glucuronidase in intestinal microflora in the intestinal toxicity of the antitumor camptothecin derivative irinotecan hydrochloride (CPT-11) in rats. Cancer Res 1996; 56:3752-3757.
13. Slichenmyer WJ, Donehower RC: Recent clinical advances with camptothecin analogues. In: Concepts, Mechanisms, and New Targets for Chemotherapy (Ed. Muggia FM), Kluwer Academic Publications, Boston, 1995, pp 29-43.
14. Nagai S, Yamauchi M, Andoh T, Nishizawa M, Satta T, Kodera Y, Kondou K, Akiyama S, Ito K, Takagi H: Establishment and characterization of human gastric and colonic xenograft lines resistant to CPT-11 (a new derivative of camptothecin). J Surg Oncol 1995;59:116-124.
15. Tsuro T, Matsuzaki T, Matsushita M, Saito H, Yokokura T: Antitumor effect of CPT-11, a new derivative of camptothecin against pleiotropic drug-resistant tumour in vitro and in vivo. Cancer Chemother Pharmacol 1988;21: 71-74.
16. Chen AY, Yu C, Potmesil M, Wall ME, Wani MC, Liu LF: Camptothecin overcomes MDR1-mediated resistance in human KB carcinoma cells. Cancer Res 1991;51:6039-6044.
17. Sasaki Y, Yoshida Y, Sudoh K, Hakasui H, Fujii H, Ohtsu T, Wakita H, Igarashi T, Itoh K: Pharmacological correlation between total drug concentration and lactones of CPT-11 and SN-38 in patients treated with CPT-11. Jpn J Cancer Res 1995;86:111-116.
18. Rivory LP, Chatelut E, Canal P, Mathieu-Boue A, Robert J: Kinetics of the in vivo interconversion of the carboxylate and lactone forms of irinotecan (CPT-11) and of its metabolite SN-38 in patients. Cancer Res 1994;54:6330-6333.
19. Rothenberg ML, Kuhn JG, Burris HA 3d, Nelson J, Eckardt JR, Tristan-Morales M, Hilsenbeck SG, Weiss GR, Smith LS, Rodriguez GI, Rock MK, Von Hoff DD: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 1993;11:2194-2204.
20. Rowinsky EK, Grochow LB, Ettinger DS, Sartorius SE, Lubejko BG, Chen TL, Rock MK, Donehower RC: Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4(1-piperidino-)-1-piperidino] carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res 1994; 54:427-436.
21. Lokiec F, Canal P, Gay C, Chatelut E, Armand JP, Roche H, Bugat R, Goncalves E, Mathieu-Boue A: Pharmacokinetics of irinotecan and its metabolites in human blood, bile, and urine. Cancer Chemother Pharmacol 1995;36:79-82.
22. Rivory LP, Robert J: Identification and kinetics of a beta-glucuronide metabolite of SN-38 in human plasma after administration of the camptothecin derivative irinotecan. Cancer Chemother Pharmacol 1995;36:176-179.
23. Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ: Metabolic fate of irinotecan in humans: correlation of glucuronidation with diarrhea. Cancer Res 1994;54:3723-3725.
24. Chabot GG, Abigerges D, Catimel G, Culine S, deForni M, Extra JM, Majoubi M, Herait P, Armand JP, Bugat R, Clavel M, Marty ME: Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol 1995; 6:141-151.
25. Canal P, Gay C, Dezeuze A, Douillard JY, Bugat R, Brunet R, Adenis A, Herait P, Lokiec F, Mathieu-Boue A: Pharmacokinetics and pharmacodynamics of irinotecan during a phase II clinical trial in colorectal cancer. J Clin Oncol 1996;14:2688-2695.
26. Chabot GG: Limited sampling models for simultaneous estimation of the pharmacokinetics of irinotecan and its active metabolite SN-38. Cancer Chemother Pharmacol 1995;36:463-472.
27. Masuda N, Fukuoka M, Takada M, Kusunoki Y, Negoro S, Matsui K, Kudoh S, Takifuji N, Nakagawa K, Kishimoto S: CPT-11 in combination with cisplatin for advanced non-small cell lung cancer. J Clin Oncol 1992;10: 1775-1780.
28. Taguchi T, Wakui A, Hasegawa K, Niitani H, Furue H, Ohta K, Hattori T: Phase I clinical study of CPT-11. Jpn J Chemother 1990;17:115-120.
29. Abigerges D, Chabot GG, Armand JP, Herait P, Gouyette A, Gandia D: Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 1995;13:210-221.
30. Catimel G, Chabot GG, Guastalla JP, Dumortier A, Cote C, Engel C, Gouyette A, Mathieu-Boue A, Mahjoubi M, Clavel M: Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for 3 consecutive days every three weeks in patients with advanced solid rumors. Ann Oncol 1995;6:133-140.
31. de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, Madelaine I, Mart ME: Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res 1994;54:4347-4354.
32. Negoro S, Fukuoka M, Masuda N, Takada M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Niitani H, Taguchi T: Phase I study of weekly intravenous infusions of camptothecin-11, a new derivative of camptothecin, in the treatment of advanced non-small cell lung cancer. J Natl Cancer Inst 1991;83:1164-1168.
33. Yasutsan S, Shinkai T, Eguchi K, Tamura T, Kojima A, Kunikane H, Okamato H, Karato A, Ohnatsu H, Kanzawa F, Saijo N: Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst 1992;84:972-974.
34. Abigerges D, Armand JP, Chabot G, Da Costa L, Fadel E, Cote C, Herait P, Gandia D: Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea. J Natl Cancer Inst 1994;86:446-449.
35. Conti JA, Kemeny NE, Saltz LB, Huang Y, Tong WP, Chou T-C, Sun M, Pulliam S, Gonzalez C: Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J Clin Oncol 1996;14:709-715.
36. Rougier PH, Culine S, Bugat R, Brunet P, Douillard JY, Ychou M, Marty M, Bonneterre J, Ganem G, Seitz JF, Negrier S, Namer M, Conroy T, Burki F, Shearrer A, Droz JP, Mathieu-Boue A, Mahjoubi M, Herait P: Multicentric phase II study of first line CPT-11 (irinotecan) in advanced colorectal cancer (CRC): preliminary results. Proc Am Soc Clin Oncol 1994;13:200 (abstract).
37. Pitot HC, Wender D, O'Connell MJ, Wieand HS, Mailliard JA: A phase II trial of CPT-11 (irinotecan) in patients with metastatic colorectal carcinoma: a North Central Cancer Treatment Group (NCCTG) study. Proc Am Soc Clin Oncol 1994;13:197 (abstract).
38. Bugat R, Rougier P, Douillard JY, Brunet R, Ychou M, Adenis A, Marty M, Seitz JF, Conroy T, Merouche Y, Ganem G, Namer M, Burki F, Mousseau M, Mahjoubi M: Efficacy of irinotecan hcl (camptothecin11) in patients with metastatic colorectal cancer after progression while receiving a 5FU-based chemotherapy. Proc Am Soc Clin Oncol 1995;14:222 (abstract).
39. Rothenberg ML, Eckardt JR, Kuhn JG, Burris HA III, Nelson J, Hilsenbeck SG, Rodriguez GI, Thurman AM, Smith LS, Eckhardt SG, Weiss GR, Elfring GL, Rinaldi DA, Schaaf LJ, Von Hoff DD: Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 1996;14:1128-1135.
40. Shimada Y, Yoshino M, Wakui A, Nakao I, Futatsuki K, Sakata Y, Kambe M, Taguchi T, Ogawa N, CPT-11 Gastrointestinal Cancer Study Group: Phase II study of CPT-11, a new camptothecin derivative in metastatic colorectal cancer. J Clin Oncol 1993;11:909-913.
41. Kambe M, Wakui A, Nakao K, Futatsuki K, Sakata Y, Yoshino M, Shimada Y, Taguchi T, CPT-11 Gastrointestinal Cancer Study Group: A late phase II study of irinotecan (CPT-11) in patients with advanced gastric cancer. Proc Am Soc Clin Oncol 1993;12:198 (abstract).
42. Sakata Y, Wakui A, Nakao I, Futatsuki K, Kambe M, Yoshino M, Shimada Y, Taguchi T, CPT-11 Gastrointestinal Cancer Study Group: A late phase II study of irinotecan (CPT-11) in advanced pancreatic cancer. Proc Am Soc Clin Oncol 1993;12:211 (abstract).
43. Wagener DJ, Verdonk HE, Dirix LY, Catimel G, Siegenthaler P, Buitenhuis M, Mathieu-Boue A, Verweij J: Phase II trial of CPT-11 in patients with advanced pancreatic cancer, an EORTC early clinical trials group study. Ann Oncol 1995;6:129-132.
44. Kudoh S, Kurihara N, Okishio K, Hirata K, Yoshikawa J, Masuda N, Takada M, Takeda K, Negoro S, Fukuoka M: A phase I-II study of weekly irinotecan (CPT-11) and simultaneous thoracic radiotherapy (TRT) for unresectable advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 1996;15:372 (abstract).
45. Okamoto H, Nagatomo A, Kunitoh H, Watanabe K: A combination phase I-II shady of carboplatin/irinotecan plus G-CSF with the Calvert equation in patients with advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 1995;14:373 (abstract).
46. Goto K, Nishiwaki Y, Saijo N, Nakabayashi T, Kawakami Y, Fujita A, Tobise K, Abe S, Suzuki S, Tsuchiya S, Takahashi S, Hayashi I, Noda K, Kurita Y, Matsuda T, Tamura T, Shimoyama M: A phase II study of irinotecan (CPT-11) and etoposide (VP-16) for metastatic non-small cell lung cancer (NSCLC): Japanese Clinical Oncology (JCOG) trial. Proc Am Soc Clin Oncol 1995;14:362 (abstract).
47. Douillard JY, Ibrahim N, Riviere A, Spaeth D, Chomy P, Soussan K, Matthieu-Boue A: Phase II study of CPT-11 in non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 1995;14:365 (abstract).
48. Nakagawa K, Fukuoka M, Niitani H, CPT-11 Lung Cancer Study Group: Phase II study of irinotecan (CPT-11) and cisplatin in patients with advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 1993;12: 332 (abstract).
49. Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N, Nakajima S, Taguchi T: A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small cell lung cancer. J Clin Oncol 1992;10:16-20.
50. Kaufman SH: Antagonism between camptothecin and topoisomerase II-directed chemotherapeutic agents in a human leukemia cell line. Cancer Res 1991;51:1129-1136.
51. Bertrand R, O'Connor MP, Kerrigan D, Pommier Y: Sequential administration of camptothecin and etoposide circumvents the antagonistic cytotoxicity of simultaneous drug administration in slowly growing human colon carcinoma HT-29 cells. Eur J Cancer 1992;28A:743-748.
52. Masuda N, Fukuoka M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Negoro S, Nishioka M, Nakagawa K, Takada M: CPT-11: a new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 1992;10:1225-1229.
53. Fujiwara Y, Yamakido M, Fukuoka M, Kudoh S, Furuse S, Ikegami H, Ariyoshi Y: Phase II study of irinotecan (CPT-11) and cisplatin (CDDP) in patients with small cell lung cancer (SCLC). Proc Am Soc Clin Oncol 1994; 13:335 (abstract).
54. Chevallier B, Lhomme C, Dieras V, Venin PH, Chauvergne J, Rebattu P, Fumoleau P, Roche H, Krakowski Y, Lentz A, Mathieu Boue A, Van Glabbecke M: Phase II trial of camptothecin11 in advanced cervical carcinoma. Proc Am Soc Clin Oncol 1995;14:267 (abstract).
55. Kavanagh JJ, Kudelka AP, Freedman RS, Edwards CL, Steger M, Ende K, Mante R, Verschraegen CF: Phase II study of irinotecan (CPT-11) in refractory cervical cancer. Proc Am Soc Clin Oncol 1996;15:281 (abstract).
56. Potkul RK, Price FV, Bailey H, Gelder M, Rosenbluth R, Durivage HJ: Irinotecan (CPT-11) in advanced squamous cell carcinoma of the cervix (phase II). Proc Am Soc Clin Oncol 1995;14:279 (abstract).
57. Taguchi T: Clinical studies of CPT-11 in Japan. Jpn J Cancer Chemother 1995;22(Suppl 3):277-283.
58. Sugiyama T, Nishida T, Ushijima K, Kumagai S, Yskushiji M: Irinotecan hydrochloride (CPT-11) combined with cisplatin (CDDP) in patients with relapsed or metastatic ovarian cancer. Proc Am Soc Clin Oncol 1996; 15:291 (abstract).
59. Shimizu Y, Umezawa S, Hasumi K: Combination of CPT-11 (camptothecin) with mitomycin-C (MMC) is active for clear cell adenocarcinoma of the ovary (OCA) which is intrinsically CDDP-resistant. Proc Am Soc Clin Oncol 1996;15:282 (abstract).
60. Ohno R, Okada K, Masaoka T, Kuramoto A, Arima T, Yoshida Y, Ariyoshi H, Ichimaru M, Sakai Y, Oguro M, Ito Y, Morishima Y, Yokomaku S, Ota K: An early phase II study of CPT-11: a new derivative of camptothecin, for the treatment of leukemia and lymphoma. J Clin Oncol 1990;8:1907-1912.
61. Tsuda H, Takatsuki K, Ohno R, Masaoka T, Okada K, Shirakawa S, Ohashi Y, Ohta K, Taguchi T, CPT-11 Study Group on Hematological Malignancies: A late phase II trial of a potent topoisomerase I inhibitor, camptothecin-11, in malignant lymphoma. Proc Am Soc Clin Oncol 1992;11:316 (abstract).
62. Tsuda H, Takatsuki K, Ohno R, Masaoka T, Okada K, Shirakawa S, Ohashi Y, Ota K, CPT-11 Study Group on Hematological Malignancies: Treatment of adult T-cell leukaemia-lymphoma with irinotecan hydrochloride (CPT-11). Br J Cancer 1994;70:771-774.