A phase I study of sequential irinotecan and 5-fluorouracil/leucovorin

Annals of Oncology

Volumn 13, Issue 10, 2002, Pages 1674-1680

  Goldberg, R M ^a   Kaufmann, S H ^a   Atherton, P ^a   Sloan, J A ^a   Adjei, A A ^a   Pitot, H C ^a   Alberts, S R ^a   Rubin, J ^a   Miller, L L ^b   Erlichman, C ^a  

^a MAYO CLINIC   (United States)

^b PFIZER INC   (United States)

Author keywords

5 Fluorouracil; Irinotecan; Leucovorin; Phase I

Indexed keywords

FLUOROURACIL; FOLINIC ACID; GRANISETRON; IRINOTECAN; LOPERAMIDE;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; CARDIOTOXICITY; CLINICAL TRIAL; COHORT ANALYSIS; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG SAFETY; FATIGUE; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; LIVER TOXICITY; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; NEPHROTOXICITY; NEUROTOXICITY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; STOMACH CANCER; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FATIGUE; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRAVENOUS; LEUCOVORIN; MALE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA;

EID: 0036808987     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdf260     Document Type: Article

References (52)

1. Shimada Y, Rothenberg M, Hilsenbeck SG et al. Activity of CPT-11 (irinotecan hydrochloride), a topoisomerase I inhibitor, against human tumor colony-forming units. Anticancer Drugs 1994; 5: 202-206.
2. Kunimoto T, Nitta K, Tanaka T et al. Antitumor activity of 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothec in a novel water-soluble derivative of camptothecin, against murine tumors. Cancer Res 1987; 47: 5944-5947.
3. 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 1991; 28: 192-198.
4. Moertel CG, Schutt AJ, Reitemeier RJ, Hahn RG. Phase II study of camptothecin (NSC-100880) in the treatment of advanced gastrointestinal cancer. Cancer Chemother Rep 1972; 56: 95-101.
5. Gottlieb JA, Luce JK. Treatment of malignant melanoma with camptothecin (NSC-100880). Cancer Chemother Rep 1972; 56: 103-105.
6. Muggia FM, Creaven PJ, Hansen HH et al. Phase I clinical trial of weekly and daily treatment with camptothecin (NSC-100880): correlation with preclinical studies. Cancer Chemother Rep 1972; 56: 515-521.
7. 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.
8. Kawato Y, Aonuma M, Hirota Y et al. Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res 1991; 51: 4187-4191.
9. Rivory LP, Riou JF, Haaz MC et al. Identification and properties of a major plasma metabolite of irinotecan (CPT-11) isolated from the plasma of patients. Cancer Res 1996; 56: 3689-3694.
10. Pommier Y, Tanizawa A, Kohn KW. Mechanisms of topoisomerase I inhibition by anticancer drugs. Adv Pharmacol 1994; 29B: 73-92.
11. Hsiang YH, Lihou MG, Liu LF. Arrest of replication forks by drug-stabilized topoisomerase I-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res 1989; 49: 5077-5082.
12. Holm C, Covey JM, Kerrigan D, Pommier Y. Differential requirement of DNA replication for the cytotoxicity of DNA topoisomerase I and II inhibitors in Chinese hamster DC3F cells. Cancer Res 1989; 49: 6365-6368.
13. Shin CG, Snapka RM. Exposure to camptothecin breaks leading and lagging strand simian virus 40 DNA replication forks. Biochem Biophys Res Common 1990; 168: 135-140.
14. Kaufmann SH. Cell death induced by topoisomerase-targeted drugs: more questions than answers. Biochim Biophys Acta 1998; 1400: 195-211.
15. 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 1993; 11: 909-913.
16. Rothenberg ML, Eckardt JR, Kuhn JG et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 1996; 14: 1128-1135.
17. Pitot HC, Wender DB, O'Connell MJ et al. Phase II trial of irinotecan in patients with metastatic colorectal carcinoma. J Clin Oncol 1997; 15: 2910-2919.
18. 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. J Clin Oncol 1992; 10: 16-20.
19. 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 1992; 10: 1225-1229.
20. Taguchi T, Tominaga T, Ogawa M et al. A late phase II study of CPT-11 (irinotecan) in advanced breast cancer. CPT-11 Study Group on Breast Cancer. Gan to Kagaku Ryoho 1994; 21: 1017-1024.
21. Takeuchi S, Dobashi K, Fujimoto S et al. A late phase II study of CPT-11 on uterine cervical cancer and ovarian cancer. Research Groups of CPT-11 in Gynecologic Cancers. Gan to Kagaku Ryoho 1991; 18: 1681-1689.
22. Bleiberg H. CPT-11 in gastrointestinal cancer. Eur J Cancer 1999; 35: 371-379.
23. Cunningham D, Pyrhonen S, James RD et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998; 352: 1413-1418.
24. Rougier P, Van Cutsem E, Bajetta E et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 1998; 352: 1407-1412.
25. Berger SH, Hakala MT. Relationship of dUMP and free FdUMP pools to inhibition of thymidylate synthase by 5-fluorouracil. Mol Pharmacol 1984; 25: 303-309.
26. Houghton JA, Maroda SJ, Phillips JO, Houghton PJ. Biochemical determinants of responsiveness to 5-fluorouracil and its derivatives in xenografts of human colorectal adenocarcinomas in mice. Cancer Res 1981; 41: 144-149.
27. Project ACCM-A. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J Clin Oncol 1992; 10: 896-903.
28. Anonymous. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators. Lancet 1995; 345: 939-944.
29. O'Connell MJ, Laurie JA, Kahn M et al. Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer. J Clin Oncol 1998; 16: 295-300.
30. Wolmark N, Rockette H, Fisher B et al. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol 1993; 11: 1879-1887.
31. Haller DG, Catalano PJ, Macdonald JS, Mayer RJ. Fluorouracil (FU), leucovorin (LV), and levamisole (LEV) adjuvant therapy for colon cancer: four-year results of INT-0089. Proc Am Soc Clin Oncol 1997; 16: 265a (Abstr 940).
32. Saltz LB, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2001; 344: 306-307.
33. Douillard JY, Cunningham D, Roth AD et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000; 355: 1041-1047.
34. Erlichman C, Goldberg RM, O'Connell MJ. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2001; 344: 305-307.
35. Sargent DJ, Niedzwiecki D, O'Connell MJ, Schilsky RL. Recommendation for caution with irinotecan, fluorouracil, and leucovorin for colorectal cancer. N Engl J Med 2001; 345: 144-145.
36. Mullany S, Svingen PA, Kaufmann SH, Erlichman C. Effect of adding the topoisomerase I poison 7-ethyl-10-hydroxycamptothecin (SN-38) to 5-fluorouracil and folinic acid in HCT-8 cells: elevated dTTP pools and enhanced cytotoxicity. Cancer Chemother Pharmacol 1998; 42: 391-399.
37. Tsao YP, D'Arpa P, Liu LF. The involvement of active DNA synthesis in camptothecin-induced G2 arrest: altered regulation of p34cdc2/cyclin B. Cancer Res 1992; 52: 1823-1829.
38. Mans DR, Grivicich I, Peters GJ, Schwartsmann G. Sequence-dependent growth inhibition and DNA damage formation by the irinotecan-5-fluorouracil combination in human colon carcinoma cell lines. Eur J Cancer 1999; 35: 1851-1861.
39. Pavillard V, Formento P, Rostagno P et al. Combination of irinotecan (CPT11) and 5-fluorouracil with an analysis of cellular determinants of drug activity. Biochem Pharmacol 1998; 56: 1315-1322.
40. Guichard S, Caliaro MJ, Houin G. Sequential expsoure of CPT-11 and 5FU is synergistic in human colon carcinoma. Proc Am Assoc Cancer Res 1996; 37: 292 (Abstr 1987).
41. Parnes HL, Tait N, Conley B, Vanecho D. A phase I study of CPT-11, weekly bolus 5-FU and leucovorin in patients with metastatic cancer. Oncol Rep 1995; 2: 1131-1134.
42. Machover D, Grison X, Goldschmidt E et al. Fluorouracil combined with the pure (6S)-stereoisomer of folinic acid in high doses for treatment of patients with advanced colorectal carcinoma: a phase I-II study. J Natl Cancer Inst 1992; 84: 321-327.
43. Pitot HC, Goldberg RM, Reid JM et al. Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy. Clin Cancer Res 2000; 6: 2236-2244.
44. 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 1994; 86: 446-449.
45. Buroker TR, O'Connell MJ, Wieand HS et al. Randomized comparison of two schedules of fluorouracil and leucovorin in the treatment of advanced colorectal cancer. J Clin Oncol 1994; 12: 14-20.
46. Grem JL. 5-Fluoropyrimidines in Cancer Chemotherapy and Biotherapy: Principles and Practice. In Chabner BA, Longo DL (eds): Philadelphia, PA: Lippincott, Williams and Wilkins; 185-264.
47. Morton RF, Goldberg RM, Sargent DJ et al. Oxaliplatin (OXAL) or CPT-11 combined with 5FU/Leucovorin (LV) in advanced colorectal cancer (CRC): An NCCTG/CALGB study. Proc Am Soc Clin Oncol 2001; 20: 125.
48. Saltz LB, Cox JV, Blanke C et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000; 343: 905-914.
49. Saltz LB, Kanowitz J, Kemeny NE et al. Phase I clinical and pharmacokinetic study of irinotecan, fluorouracil, and leucovorin in patients with advanced solid tumors. J Clin Oncol 1996; 14: 2959-2967.
50. Petrelli N, Douglass HO Jr, Herrera L et al. The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomized phase III trial. Gastrointestinal Tumor Study Group. J Clin Oncol 1989; 7: 1419-1426.
51. de Gramont A, Bosset JF, Milan C et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 1997; 15: 808-815.
52. Kohne CH, Schoffski P, Wilke H et al. Effective biomodulation by leucovorin of high-dose infusion fluorouracil given as a weekly 24-hour infusion: results of a randomized trial in patients with advanced colorectal cancer. J Clin Oncol 1998; 16: 418-426.