US pivotal studies of irinotecan in colorectal carcinoma

ONCOLOGY

Volumn 12, Issue 8 SUPPL., 1998, Pages 48-53

  Pitot, Henry C ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; DEXAMETHASONE; DNA TOPOISOMERASE INHIBITOR; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; LOPERAMIDE; METHOTREXATE; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SEROTONIN ANTAGONIST; SPARFOSIC ACID;

ANTINEOPLASTIC ACTIVITY; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL PROTOCOL; CLINICAL TRIAL; COLORECTAL CARCINOMA; CONFERENCE PAPER; DIARRHEA; DOSE RESPONSE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; META ANALYSIS; NAUSEA; NEUTROPENIA; NONHUMAN; ORAL DRUG ADMINISTRATION; TREATMENT OUTCOME; UNITED STATES; VOMITING;

EID: 0031796145     PISSN: 08909091     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (38)

1. Landis SH, Murray T, Bolden S et al: Cancer statistics, 1998. CA Cancer J Clin 48:6-29, 1998.
2. Curreri AR, Ansfield FJ, McIver FA, et al: Clinical studies with 5-fluorouracil. Cancer Res 18:748-784, 1958.
3. Moertel CG: Chemotherapy for colorectal cancer. N Engl J Med 330:1136-1142, 1994.
4. Advanced Colorectal Cancer Meta-Analysis Project. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 10:896-903, 1992.
5. Poon MA, O'Connell MJ, Wieand HS, et al: Biochemical modulation of fluorouracil with leu- covorin: Confirmatory evidence of improved therapeutic efficacy in advanced colorectal cancer. J Clin Oncol 9:1967-1972, 1991.
6. Erlichman C, Fine S, Wong A, et al: A randomized trial of fluorouracil and folinic acid in patients with metastatic colorectal carcinoma. J Clin Oncol 6:469-475, 1988.
7. Leichman CG, Fleming TR, Muggia FM, et al: Phase II study of fluorouracil and its modulation in advanced colorectal cancer: A Southwest Oncology Group Study. J Clin Oncol 13:1303-1311, 1995.
8. The Meta-Analysis Group in Cancer: Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 16:301-308, 1998.
9. Wall ME, Wani MC, Gook CE, et al: Plant antttumor agents: 1. The isolation and structure of camptothecin, a novel alkaloid leukemia and tumor inhibitor from Camptotheca acuminata. J Am Chem Soc 88:3888-3890, 1966.
10. DeWys WD, Humphreys SR, Goldin A: Studies on therapeutic effectiveness of drugs with tumor weight and survival time indices of Walker 256 carcinosarcoma. Cancer Chemother Rep 52:229-242, 1968.
11. Gottlieb JA, Guarino AM, Call JB, et al: Preliminary pharmacologic and clinical evaluation of camptothecin sodium (NSC-100880). Cancer Chemother Rep 54:461-470, 1970
12. Moertel CG, Schutt AJ, Reitemeier RJ, et al: Phase II study of camptothecin (NSC-100880) in the treatment of advanced gastrointestinal cancer. Cancer Chemother Rep 56:95-101, 1972.
13. Gottlieb J, Luce JK: Treatment of malignant melanoma with camptothecin (NSC-100880). Cancer Chemother Rep 56:103-105, 1972.
14. Marsoni S, Hoth D, Simon R, et al: Clinical drug development: An analysis of phase II trials, 1970-1985. Cancer Treat Rep 71:71-80, 1987.
15. Bedikian AY, Stroehlein J, Korinek J et al: A comparative study of oral tegafur and intravenous 5-fluorouracil in patients with metastatic colorectal cancer. Am J Clin Oncol 6:181-186, 1983
16. Kunimoto T, Nitta K, Tanaka T, et al: Antitumor activity of 7-ethyl-10-[4-(1-pipendino)-1-piperidino] carbonyloxy-camptothecin, a novel water-soluble derivative of camptothecin, against murine tumors. Cancer Res 47:5944-5947, 1987.
17. Hsiang YH, Liu LF: Identification of mammalian DNA topoisomerase I as an intracellular target of the anticancer drug camptothecin. Cancer Res 48:1722-1726, 1988.
18. Hsiang YH, Hertzberg R, Hecht S, et al: Camptothecin induces protein-linked DNA brakes via mammalian DNA topoisomerase-I J Biol Chem 260:14873-14878, 1985.
19. Slichenmeyer WJ, Rowinsky EK, Donehower RC, et al: The current status of camptothecin analogues as antitumor agents. J Natl Cancer Inst 85:271-291, 1993
20. Pommier Y. Eukaryotic DNA topoisomerase-I: Genome gatekeeper and its intruders, camptothecins. Semin Oncol 23(suppl 3):3-10, 1996
21. Kawato Y, Aonuma M, Hirota Y, et al: Intracellular roles of SN-38, a metabolite of camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res 51:4187-4191, 1991.
22. Giovanella BC, Stehlin JS, Wall ME, et al: DNA topoisomerase I-targeted chemotherapy of human colon cancer in xenografts. Science 246:1046-1048, 1989.
23. Houghton PJ, Cheshire PJ, Hallman JC, et al: Efficacy of topoisomerase-I inhibitors, topotecan, and irinotecan administered at low-dose levels in protracted schedules in mice bearing xenografts of human tumors. Cancer Chemother Pharmacol 36:393-403, 1995.
24. Negoro S, Fukuoka M, Masuda N, et al: Phase, I study of weekly intravenous infusion of CPT-11, a derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991.
25. Armand JP: CPT-11: Clinical experience in phase I studies. Semin Oncol 23(suppl 3):27-33, 1996.
26. 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.
27. Rowinsky EK, Grochow LB, Ettinger DS, et al: Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-(4-(1-piperidinu)-1-piperidino] carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every three weeks. Cancer Res 54:427-436, 1994.
28. Rothenberg ML, Kuhn JG, Burris III HA, et al: Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol 11:2194-2204, 1993.
29. Lestingi TM, Vokes EB, Gray W, et al: A phase I trial of CPT-11 in solid tumors with G-CSF and antidiarrheal support. Proc Am Soc Clin Oncol 14:480, 1995.
30. Rothenberg ML, Rinaldi DA, Smith LS, et al: Every-other-week irinotecan (CPT-11): Results of a phase I and pharmacokinetic study. Proc Am Soc Clin Oncol 15:489, 1996.
31. Shimada Y, Yoshino M, Wakui A, et al: Phase II sludy of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. J Clin Oncol 10:909-913, 1993
32. 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 14:1128-1135, 1996.
33. Pitot HC, Wender DB, O'Connell MJ, et al: A phase II trial if irinotecan (CPT-11) in patients with metastatic colorectal carcinoma. J Clin Oncol 15:2910-2919, 1997.
34. 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.
35. 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 86:46-49, 1994.
36. Von Hoff DD, Rothenberg ML, Pitot HC, et al: Irinotecan (CPT-11) therapy for patients with previously treated metastatic colorectal cancer (CRC): Overall results of FDA-reviewed pivotal US clinical trials. Proc Am Soc Clin Oncol 16:228a, 1997.
37. Pazdur R, Zinner R, Rothenberg ML, et al: Age as a risk factor in irinotecan (CPT-11) treatment of 5-FU refractory colorectal cancer. Proc Am Soc Clin Oncol 16:200a, 1997.
38. 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 14:2959-2967, 1996.