Direct translation of a protracted irinotecan schedule from a xenograft model to a phase I trial in children

Journal of Clinical Oncology

Volumn 17, Issue 6, 1999, Pages 1815-1824

  Furman, Wayne L ^a   Stewart, Clinton F ^a   Poquette, Catherine A ^a   Pratt, Charles B ^a   Santana, Victor M ^a   Zamboni, William C ^a   Bowman, Laura C ^a   Ma, Margaret K ^a   Hoffer, Fredrick A ^a   Meyer, William H ^a   Pappo, Alberto S ^a   Walter, Andrew W ^a   Houghton, Peter J ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; IRINOTECAN;

ADOLESCENT; ADULT; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CHILD; CHILDHOOD CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG BINDING; DRUG CLEARANCE; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MOUSE; NEUROBLASTOMA; NONHUMAN; OSTEOSARCOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RHABDOMYOSARCOMA; SOLID TUMOR; TUMOR XENOGRAFT;

EID: 0033039308     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.1999.17.6.1815     Document Type: Article

References (56)

1. Smith M, Bernstein M, Bleyer WA, et al: Conduct of phase I trials in children with cancer. J Clin Oncol 16:966-978, 1998
2. Smith M, Ho PT: Pediatric drug development: A perspective from the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Invest New Drugs 14:11-22, 1996
3. MacArthur CA, Vietti T: The importance of phase I/II trials in pediatric oncology. Invest New Drugs 14:33-35, 1996
4. Estlin EJ, Ablett S, Newell DR, et al: Phase I trials in paediatric oncology: The European perspective - The New Agents Group of the United Kingdom Childrens Cancer Study Group. Invest New Drugs 14:23-32, 1996
5. Tsuji T, Kaneda N, Kado K, et al: CPT-11 converting enzyme from rat serum: Purification and some properties. J Pharmacobiodyn 14:341-349, 1991
6. 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 I inhibitor 9-dimethylaminomethyl-10-hydroxycamptothecin. Cancer Res 53:2823-2829, 1993
7. Houghton PJ, Cheshire PJ, Hallman JD II, et al: Efficacy of topoisomerase I 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
8. 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
9. Kudoh S, Fukuoka M, Masuda N, et al: Relationship between the pharmacokinetics of irinotecan and diarrhea during combination chemotherapy with cisplatin. Jpn J Cancer Res 86:406-413, 1995
10. Abigerges D, Chabot GG, Armand JP, et al: Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 13:210-221, 1995
11. Catimel G, Chabot GG, Guastalla JP, et al: Phase I and pharmacokinetic study of irinotecan (CPT-11) administered daily for three consecutive days every three weeks in patients with advanced solid tumors [see comments]. Ann Oncol 6:133-140, 1995
12. de Forni M, Bugat R, Chabot GG, et al: Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res 54:4347-4354, 1994
13. Rothenberg ML, Kuhn JG, Burris HA III, et al: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 11:2194-2204, 1993
14. Rowinsky EK, Grochow LB, Ettinger DS, et al: 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 54:427-436, 1994
15. Fukuoka M, Niitani 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 [see comments]. J Clin Oncol 10:16-20, 1992
16. Kambe M, Wakui A, Nakao I, et al: A late phase II study of irinotecan (CPT-11) in patients (pts) with advanced gastric cancer. Proc Am Soc Clin Oncol 12:198, 1993 (abstr 584)
17. 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
18. Masuda N, Fukuoka M, Takada M, et al: CPT-11 in combination with cisplatin for advanced non-small-cell lung cancer. J Clin Oncol 10:1775-1780, 1992
19. Sakata Y, Wakui A, Nakao I, et al: A late phase II study of irinotecan (CPT-11) in advanced pancreatic cancer. Proc Am Soc Clin Oncol 12:211, 1993 (abstr 633)
20. Shimada Y, Yoshino M, Wakui A, et al: Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer: CPT-11 Gastrointestinal Cancer Study Group. J Clin Oncol 11:909-913, 1993
21. Takeuchi S, Takamizawa H, Takeda Y, et al: Clinical study of CPT-11, camptothecin derivative, on gynecological malignancy. Proc Am Soc Clin Oncol 10:189, 1991 (abstr 617)
22. Tsuda H, Takatsuki K, Ohno R, et al: Treatment of adult T-cell leukaemia-lymphoma with irinotecan hydrochloride (CPT-11): CPT-11 Study Group on Hematological Malignancy. Br J Cancer 70:771-774, 1994
23. Wagener DJ, Verdonk HE, Dirix LY, et al: Phase II trial of CPT-11 in patients with advanced pancreatic cancer: An EORTC early clinical trials group study [see comments], Ann Oncol 6:129-132, 1995
24. 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
25. 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
26. Giovanella BC, Stehlin JS, Wall ME, et al: DNA topoisomerase I-targeted chemotherapy of human colon cancer in xenografts. Science 246:1046-1048, 1989
27. Hare CB, Elion GB, Houghton PJ, et al: Therapeutic efficacy of the topoisomerase I inhibitor 7-ethyl-10-(4-[1-piperidino]-carbonyloxy)-camptothecin against pediatric and adult central nervous system tumor xenografts. Cancer Chemother Pharmacol 39:187-191, 1997
28. Kunimoto T, Nitta K, Tanaka T, et al: Antitumor activity of 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin, a novel water-soluble derivative of camptothecin, against murine tumors. Cancer Res 47:5944-5947, 1987
29. Thompson J, Zamboni WC, Cheshire PJ, et al: Efficacy of systemic or oral administration of irinotecan against neuroblastoma xenografts. Clin Cancer Res 3:423-431, 1997
30. Zamboni WC, Stewart CF, Thompson J, et al: Relationship between topotecan systemic exposure and tumor response in human neuroblastoma xenografts. J Natl Cancer Inst 90:505-511, 1998
31. Kalbfleisch, JD, Prentice RL: Inference based on ranks in the accelerated failure time model, in The Statistical Analysis of Failure Time Data. New York, NY, Wiley, 1980, pp 143-161
32. Conover WJ: Some methods based on ranks, in Practical Nonparametric Statistics. New York, NY, Wiley, 1980, pp 232-234
33. Hochberg Y, Tamhane A: Single-step procedures for pairwise and more general comparisons among all treatments, in Multiple Comparison Procedures. New York, NY, Wiley, 1987, pp 94-96
34. 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
35. Zamboni WC, Stewart CF, Cheshire PJ, et al: Studies of the efficacy and pharmacology of irinotecan against human colon xenograft models. Clin Cancer Res 4:743-753, 1998
36. Zamboni WC, Houghton PJ, Thompson J, et al: Altered irinotecan and SN-38 disposition after intravenous and oral administration of irinotecan in mice bearing human neuroblastoma xenografts. Clin Cancer Res 4:455-463, 1998
37. Gibaldi M, Perrier D: Multi-compartment models, in Multicompartmental Models: Pharmacokinetics. New York, NY, Marcel Dekker, 1982, pp 45-111
38. Rivory LP, Haaz MC, Canal P, et al: Pharmacokinetic interrelationships of irinotecan (CPT-11) and its three major plasma metabolites in patients enrolled in phase I/II trials. Clin Cancer Res 3:1261-1266, 1997
39. Conti JA, Kemeny NE, Saltz LB, et al: Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J Clin Oncol 14:709-715, 1996
40. Abigerges D, Armand JP, Chabot GG, et al: Irinotecan (CPT-11) high-dose escalation using intensive high-dose loperamide to control diarrhea. J Natl Cancer Inst 86:446-449, 1994
41. Negoro S, Fukuoka M, Masuda N, et al: Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991
42. Ohe Y, Sasaki Y, Shinkai T, et al: Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion. J Natl Cancer Inst 84:972-974, 1992
43. Von Hoff DD, Turner J: Response rates, duration of response, and dose response effects in phase I studies of antineoplastics. Invest New Drugs 9:115-122, 1991
44. Tubergen D, Stewart CF, Pratt CB, et al: Phase I trial and pharmacokinetic (PK) and pharmacodynamics (PD) study of topotecan using a five-day course in children with refractory solid tumors: A Pediatric Oncology Group study. J Pediatr Hematol Oncol 18:352-361, 1996
45. Smith TL, Lee JJ, Kantarjian HM, et al: Design and results of phase I cancer clinical trials: Three-year experience at M.D. Anderson Cancer Center. J Clin Oncol 14:287-295, 1996
46. Lasagna L, Frei E III: The impact of regulations, tradition, and experimental design on clinical cancer trials: Report and recommendations resulting from Washington Cancer Trials Conference. Am J Clin Oncol 19:325-329, 1996
47. Hawkins MJ: Early cancer clinical trials: Safety, numbers, and consent. J Natl Cancer Inst 85:1618-1619, 1993 (editorial; comment)
48. Ratain MJ, Mick R, Schilsky RL, et al: Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents [see comments]. J Natl Cancer Inst 85:1637-1643, 1993
49. Christian MC and Korn EL The limited precision of phase I trials. J Natl Cancer Inst 86:1662-1663, 1994 (editorial; comment)
50. American Society of Clinical Oncology: Critical role of phase I clinical trials in cancer treatment. J Clin Oncol 15:853-859, 1997
51. Arbuck SG: Workshop on phase I study design: Ninth NCI/EORTC New Drug Development Symposium, Amsterdam, March 12, 1996. Ann Oncol 7:567-573, 1996
52. Thompson J, Stewart CF, Houghton PJ: Animal models for studying the action of topoisomerase I targeted drugs. Biochim Biophys Acta 1400:301-319, 1998
53. Thompson J, Zamboni WC, Cheshire PJ, et al: Efficacy of oral irinotecan against neuroblastoma xenografts. Anticancer Drugs 8:313-322, 1997
54. Vassal G, Santos A, Deroussent A, et al: Clinical pharmacology of irinotecan (CPT-11) in children. Proc Am Soc Clin Oncol 17:187a, 1998 (abstr 720)
55. Zamboni WC, Crom WR, Houghton PJ, et al: Plasma protein binding of SN-38, the active metabolite of irinotecan. Pharmacotherapy 16:500, 1996 (abstr 66)
56. Vassal G, Santos A, Pein F, et al: Pharmacokinetics of irinotecan (CPT-11) and its metabolites in children. Proc Am Assoc Cancer Res 38:75, 1997 (abstr 505)