Preclinical and clinical results with irinotecan: Extending principles learned in model systems to clinical trials design

ONCOLOGY

Volumn 12, Issue 8 SUPPL., 1998, Pages 84-93

  Houghton, Peter J ^a,c   Stewart, Clinton F ^a   Thompson, Joyce ^b   Santana, Victor M ^a   Furman, Wayne L ^c   Friedman, Henry S ^d  

^a Department of Molecular Pharmacology ^*

^b Molecular Pharmacology

^c ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^d DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; DOXORUBICIN; IRINOTECAN; LOPERAMIDE; MELPHALAN; TOPOTECAN; VINCRISTINE; 7-ETHYL-10-HYDROXYCAMPTOTHECIN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE;

ABDOMINAL CRAMP; ADOLESCENT; ADULT; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTINEOPLASTIC ACTIVITY; CANCER GRAFT; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; FEMALE; GLIOBLASTOMA; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; NAUSEA; NEUTROPENIA; NONHUMAN; OLIGODENDROGLIOMA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRESCHOOL CHILD; RAT; SCHOOL CHILD; VOMITING; ANIMAL; ARTICLE; BIOLOGICAL MODEL; BRAIN TUMOR; CBA MOUSE; DRUG ADMINISTRATION; DRUG SCREENING; METHODOLOGY; MOUSE;

ANIMALS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BRAIN NEOPLASMS; CAMPTOTHECIN; CHILD; CLINICAL TRIALS; CLINICAL TRIALS, PHASE I; CLINICAL TRIALS, PHASE II; DRUG ADMINISTRATION SCHEDULE; DRUG EVALUATION; FEMALE; HUMANS; MICE; MICE, INBRED CBA; MODELS, BIOLOGICAL; RESEARCH DESIGN;

EID: 0031742751     PISSN: 08909091     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (41)

1. Taguchi T, Wakui A, Hasegawa K: Phase I clinical study of CPT-11. Gan To Kagaku Ryoho 17:115-120, 1990.
2. Masuda N, Fukuoka M, Kusunoki Y, et al: CPT-11: A new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 10:1225-1229, 1992.
3. Fujita A, Takabatake H, Tagaki S, et al: Pilot study of irinotecan in refractory small-cell lung cancer. Gan To Kagaku Ryoho 22:889- 893,1995.
4. Ohno R, Okada K, Masaoka T, et al: An early phase II study of CPT-11: A new derivative of camptothecin, for the treatment of leukemia and lymphoma. J Clin Oncol 8:1907-1912, 1990.
5. Fukuoka M, Niitanim H, Suzuki A, et al: A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small- cell lung cancer. J Clin Oncol 10:16-20, 1992.
6. Fukuoka M, Masuda N: Clinical studies of irinotecan and in combination with cisplatin. Cancer Chemother Pharmacol 34(suppl):S 105-111, 1994.
7. Shimada Y, Yoshino M, Wakui A, et al: Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. J Clin Oncol 11:909-913, 1993.
8. Nishimura G, Satou T, Yoshimitsu Y, et al: Effect of chemotherapy using irinotecan (CPT- 11) against recurrent colorectal cancer. Gan To Kagaku Ryoho 22:93-97, 1995.
9. Rougier P, Culine S, Bugat R, et al: Multicentric phase II study of first line CPT-11 (irinotecan) in advanced colorectal cancer (CRC): Preliminary results (abstract). Proc Am Soc Clin Oncol 13:A585, 1994.
10. Rothenberg ML, Eckardt JR, Burris HA, et al: Irinotecan (CPT-11) as second-line therapy for patients with 5-FU-refractory colorectal cancer (abstract). Proc Am Soc Clin Oncol 13:A585, 1994
11. Pitot HC, Wender D, O'Connell MJ, et al: A phase II trial of CPT-11 (irinotecan) in patients with metastatic colorectal carcinoma: A North Central Cancer Treatment Group (NCCTG) study (abstract). Proc Am Soc Clin Oncol 13:A573, 1994.
12. Burris HA, Rothenberg ML, Kuhn JG, et al: Clinical trials with the topoisomerase I inhibitors. Semin Oncol 19:663-669, 1993.
13. Kunimoto T, Nitta K, Tanaka T, et al: Antitumor activity of 7-ethyl-10-[4-(1-piperidino)-1-piperidino]-1-carbonyloxy-camptothecin, a novel water soluble derivative of camptothecin, against murine tumors. Cancer Res 47:5944-5947, 1987.
14. Matsuzaki T, Yokokura T, Mutai M, et al: Inhibition of spontaneous and experimental metastasis by a new derivative of camptothecin, CPT- 11, in mice. Cancer Chemother Pharmacol 21:308-312, 1988.
15. Giovanella BC, Stehlin JS, Wall ME, et al: DNA topoisomerase 1-targeted chemotherapy of human colon cancer xenografts. Science 246:1046-1048, 1989.
16. Bissery MC, Mathieu-Boué A, Lavelle F: Preclinical evaluation of CPT-11, a camptothecin derivative. Proc Am Assoc Cancer Res 33:402, 1991.
17. Bissery MC, Mathieu-Boué A, Lavelle F: Experimental activity of CPT-11 in vitro and in vivo. Ann Oncol 3(suppl 1)-93, 1992.
18. Kawato Y, Furuta T, Aonuma M, et al: Antitumor activity of a camptothecin derivative, CPT-11, against human tumor xenografts in nude mice. Cancer Chemother Pharmacol 28:192-198, 1991.
19. Houghton PJ, Cheshire PJ, Hallman JC, et al:Therapeutic efficacy of the topoisomerase I inhibitor 7-ethyl-10-(4-[1-piperidino]-1-piperidino)-carbonyloxy-camptothecin against human tumor xenografts: Lack of cross resistance in vivo in tumors with acquired resistance to the topoisomerase inhibitor 9-dimethylaminomethyl-10- hydoxycamptothecin Cancer Res 53:2823-2829, 1993.
20. Houghton PJ, Cheshire PJ, Hallman JD II, et al: Efficacy of topoisomerase inhibitors, topotecan and irinotecan, administered at low dose levels in protracted schedules to mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 36:393-403, 1995.
21. Tsuruo T, Matsuzaki T, Matsushita M, et al: Antitumor effect of CPT-11, a new derivative of camptothecin, against pleiotropic drug resistant tumors in vitro and in vivo. Cancer Chemother Pharmacol 21:71-74, 1988.
22. Friedman HS, Johnson SP, Dong Q, et al: Methylator resistance mediated by mismatch repair deficiency in a glioblastoma multiforme xenograft. Cancer Res 57: 2933-2937, 1997.
23. Thompson J, Zamboni WC, Cheshire PJ, et al: Efficacy of systemic administration of irinotecan against neuroblastoma xenografts. Clin Cancer Res 3:423-431, 1997.
24. D'Argenio DZ, Schumitzky A: A program package for simulation and parameter estimationin pharmacokinetic systems. Comput Programs Biomed 9:115-134, 1979.
25. Stewart CF, Zambom WC, Crom WR, et al: Disposition of irinotecan and SN-38 following oral and intravenous irinotecan dosing in mice. Cancer Chemother Pharmacol 40: 259-265,1997.
26. Yeh KC, Kwan KC: A comparison of numerical integrating algorithms by trapezoidal, Lagrange, and spline approximation. J Pharmacokinet Biopharm 6:79-98, 1978.
27. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958.
28. Kalbfleisch JD, Prentice RL: The Statistical Analysis of Failure Time Data. New York, John Wiley & Sons, 1980.
29. Lehman, E: Nonparametrics: Statistical Methods Based on Ranks. San Francisco: Holden-Day, 1975.
30. Hare CB, Elion GB, Houghton PJ, et al: Therapeutic efficacy of the topoisomerase I inhibitor 7-ethyl-10-(4[1-pipendino]-1-piperidino)- carbonyloxy-camptothecin against pediatric and adult central nervous system tumor xenografts. Cancer Chemother Pharmacol 393:187-91,1997.
31. Kawato Y, Furuta T, Aonuma M, et al: Antitumor activity of a camptothecin derivative, CPT-11, against human tumor xenografts in nude mice. Cancer Chemother Pharmacol 28:192-198, 1991.
32. Vassal G, Terrier-Lacombe MJ, Bissery MC, et al: Therapeutic activity of CPT-11, a DNA- topoisomerase I inhibitor, against peripheral primitive neuroectodermal tumour and neuroblastoma xenografts. Br J Cancer 74:537-45, 1996.
33. Bissery MC, Vrignaud P, Lavelle F, et al: Experimental antitumor activity and pharmacokinetics of the camptothecin analog irinotecan (CPT-11) in mice. Anticancer Drugs 7:437-60, 1996.
34. Erickson-Miller CL, May RD, Tomaszewski J, et al: Differential toxicity of camptothecin, topotecan and 9-aminocamptothecin to human, canine, and murine myeloid progenitors (CFU-GM) in vitro Cancer Chemother Pharmacol 39:467-472, 1997.
35. Houghton PJ, Stewart CF, Zamboni WC, et al: Schedule-dependent efficacy of camptothecins in models of human cancer. Ann NY Acad Sci 803:188-201, 1996.
36. Furman WL, Stewart CF, Prat CB, et al: A phase I study of irinotecan (CPT-11) in children with relapsed solid tumors (abstract). Proc Am Assoc Clin Oncol, 1998 (in press).
37. Rothenberg ML, Kuhn JG, Bums HA III, et al: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 11:2194-2204, 1993.
38. Colvin OM, Cokgor I, Ashley DM, et al: Irinotecan treatment of adults with recurrent or progressive malignant glioma (abstract). Proc Am Assoc Clin Oncol, 1998 (in press).
39. Houghton PJ, Cheshire PJ, Myers L, et al: Evaluation of 9-dimethylaminomethyl-10-hydroxycamptothecin against xenografts derived from adult and childhood solid tumors. Cancer Chemother Pharmacol 31:229-239, 1992.
40. Thompson J, Zamboni WC, Cheshire PJ, et al: Efficacy of systemic administration of irinotecan against neuroblastoma xenografts. Clin Cancer Res 3:423-431, 1997.
41. Kretchmar C, Kletzel M, Murray K, et al: Upfront phase II therapy with taxol (Txl) and topotecan (Topo) in untreated children (> 365 days) with disseminated (INSS stage 4) neuroblastoma (NB): A Pediatric Oncology Group (POG) study (abstract). Med Pediatr Oncol 25:243, 1995.