Phase 1 and pharmacokinetic study of intravenous irinotecan in refractory solid tumor patients with hepatic dysfunction

Clinical Cancer Research

Volumn 12, Issue 12, 2006, Pages 3782-3791

  Schaaf, Larry J ^a,n   Hammond, Lisa A ^b   Tipping, Stuart J ^d   Goldberg, Richard M ^e,i   Goel, Rakesh ^f   Kuhn, John G ^c   Miller, Langdon L ^g,l   Compton, Linda D ^g   Cisar, Laura A ^g   Elfring, Gary L ^g   Gruia, Gabriela ^g,j   McGovren, J Patrick ^g,k   Pirotta, Nicoletta ^g,m   Yin, Donghua ^g   Sharma, Amarnath ^g   Duncan, Barbara A ^g   Rothenberg, Mace L ^h  

^a OHIO STATE UNIVERSITY   (United States)

^b Cancer Therapy Research Center   (United States)

^c UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^d MARSHFIELD CLINIC   (United States)

^e MAYO CLINIC   (United States)

^f OTTAWA REGIONAL CANCER CENTRE   (Canada)

^g PFIZER INC   (United States)

^h VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF NORTH CAROLINA   (United States)

^j NOVARTIS PHARMA AG   (Switzerland)

^k J Patrick McGovren LLC   (United States)

^l PTC THERAPEUTICS   (United States)

^m NERVIANO MEDICAL SCIENCES   (Italy)

ⁿ OHIO STATE UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

7 ETHYL 10 HYDROXYCAMPTOTHECIN; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; IRINOTECAN;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DIARRHEA; DISEASE ASSOCIATION; DOSE CALCULATION; DOSE RESPONSE; DRUG CLEARANCE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LIVER DYSFUNCTION; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MAXIMUM TOLERATED DOSE; NEUTROPENIA; PRIORITY JOURNAL; SOLID TUMOR; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; AREA UNDER CURVE; BILIRUBIN; CAMPTOTHECIN; DIARRHEA; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LIVER DISEASES; LIVER FUNCTION TESTS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA; PATIENT SELECTION;

EID: 33745725765     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-05-2152     Document Type: Article

References (45)

1. Tanizawa A, Fujimori A, Fujimori Y, et al. Comparison of topoisomerase I inhibition, DNA damage, and cytotoxicity of camptothecin derivatives presently in clinical trials. J Natl Cancer Inst 1994;86:836-42.
2. Mathijssen RHJ, van Alphen RJ, Verweij J, et al. Clinical pharmacokinetics and metabolism of irinotecan (CPT-11). Clin Cancer Res 2001;7:2182-94.
3. Mathijssen RHJ, Loos WJ, Verweij J, et al. Pharmacology of topoisomerase I inhibitors irinotecan (CPT-11) and topotecan. Curr Cancer Drug Targets 2002;2:103-23.
4. Garcia-Carbonero R, Supko J. Current perspectives on the clinical experience, pharmacology, and continued development of the camptothecins. Clin Cancer Res 2002;8:641-61.
5. Vanhoefer U, Harstrick A, Achterrath W, et al. Irinotecan in the treatment of colorectal cancer: clinical overview. J Clin Oncol 2001;19:1501-18.
6. Takimoto CH, Arbuck SG. Topoisomerase I targeting agents: the camptothecins. In: Chabner BA, Longo DL, editors. Cancer chemotherapy and biotherapy: principles and practice. 3rd ed. Philadelphia (PA): Lippincott Williams & Wilkins: 2001. p. 579-646.
7. 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;352:1413-8.
8. 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;355:1041-7.
9. Erratum in: Lancet 2000;355:1372.
10. 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;352:1407-12.
11. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2002;543:905-14.
12. Saltz LB, Douillard JY, Pirotta N, et al. Irinotecan plus fluorouracil/leucovorin for metastatic colorectal cancer: a new survival standard. Oncologist 2001;6:81-91.
13. Rocha Lima CMS, Savarese D, Bruckner H, et al. Irinotecan plus gemcitabine induced both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer. J Clin Oncol 2002;20:1182-91.
14. Ilson DH, Baines M, Kelsen DP, et al. Phase I trial of escalating-dose irinotecan given weekly with cisplatin and concurrent radiotherapy in locally advanced esophageal cancer. J Clin Oncol 2003;21:2926-32.
15. Boku N, Ohtsu A, Shimada Y et al. Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer. J Clin Oncol 1999;17:319-23.
16. Noda K, Nishiwaki Y, Kawahara M, et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 2002;346:85-91.
17. DeVore RF, Johnson DH, Crawford J, et al. Phase II study of irinotecan plus cisplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol 1999;17:2710-20.
18. Verschraegen CF, Levy T, Kudelka AP, et al. Phase II study of irinotecan in prior chemotherapy-treated squamous cell carcinoma of the cervix. J Clin Oncol 1997;15:625-31.
19. Perez EA, Hillman DW, Mailliard JA, et al. Randomized phase II study of 2 schedules of irinotecan (CPT-11) for patients with refractory metastatic breast cancer: an NCCTG cooperative group study [abstract]. Proc Am Soc Clin Oncol 2002;21:52a.
20. Friedman H, Petros WP, Friedman AH, et al. Irinotecan therapy in adults with recurrent or progressive malignant glioma. J Clin Oncol 1999;17:1516-25.
21. Gandia D, Abigerges D, Armand JP, et al. CPT-11-induced cholinergic effects in cancer patients. J Clin Oncol 1993;11:196-7.
22. 2 irinotecan (CPT-11) given every two weeks [abstract]. Proc Am Soc Clin Oncol 1997;16:268a.
23. Khanna R, Morton CL, Danks MK, et al. Proficient metabolism of irinotecan by a human intestinal carboxylesterase. Cancer Res 2000;60:4725-8.
24. Guichard S, Terret C, Hennebelle I, et al. CPT-11 converting carboxylesterase and topoisomerase activities in tumour and normal colon and liver tissues. Br J Cancer 1999;80:364-70.
25. Ahmed F, Vyas V, Cornfield A, et al. In vitro activation of irinotecan to SN-38 by human liver and intestine. Anticancer Res 1999;19:2067-71.
26. 14C]CPT-U in cancer patients. Drug Metab Dispos 2000;28:423-33.
27. Burke D, Allen-Mersh TG. Colorectal liver metastases. Postgrad Med J 1996;72:464-9.
28. Retain MJ. Pharmacology of cancer chemotherapy. In: DeVita VT, Hellman S, Rosenberg SA, editors. Cancer: principles & practice of oncology. 6th ed. Philadelphia (PA): Lippincott Williams & Wilkins: 2001. p. 335-44.
29. Wasserman E, Myara A, Lokiec F, et al. Severe CPT-11 toxicity in patients with Gilbert's syndrome: two case reports. Ann Oncol 1997;8:1049-51.
30. Ong SYK, Clark SJ, Bishop J, et al. Toxicity of irinotecan (CPT-11) and hepato-renal dysfunction. Anticancer Drugs 2001;12:619-25.
31. Van Groeningen CJ, Van der Vijgh WJF, Baars JJ, et al. Altered pharmacokinetics and metabolism of CPT-11 in liver dysfunction: a need for guidelines. Clin Cancer Res 2000;6:1342-6.
32. Raymond E, Boige V, Faivre S, et al. Dosage adjustment and pharmacokinetic profile of irinotecan in cancer patients with hepatic dysfunction. J Clin Oncol 2002;20:4303-12.
33. Venook AP, Enders Klein C, Fleming G, et al. A phase I and pharmacokinetic study of irinotecan in patients with hepatic or renal dysfunction or with prior pelvic radiation: CALGB 9863. Ann Oncol 2003;14:1783-90.
34. Simon JB. Approach to the patient with liver disease. In: Thomson ABR, Shaffer EA, editors. First principles of gastroenterology. 2nd ed. Oakville (Ontario): Canadian Association of Gastroenterology: 1994. p. 465-76.
35. Clinical features of liver disease. 17th ed In: Beers RM, Berkow R, editors. The Merck manual of diagnosis and therapy [cited 2006 Jan 21]. Available from: http://www.merck.com/mrkshared/mmanual/section4/chapter38/38b. jsp.
36. Pilot HC, Goldberg RM, Reid JM, et al. Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-3-week dosing schedule for patients with advanced solid tumor malignancy. Clin Cancer Res 2000;6:2236-44.
37. Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed New York (NY): Marcel Dekker: 1982.
38. Rivory LP, Haaz MC, Canal P, et al. Pharmacokinetic interrelationships of irinotecan (CPT-11) and its three major metabolites in patients enrolled in phase I/II trials. Clin Cancer Res 1997;3:1261-6.
39. Schaaf L, Ichhpurani N, Elfring G, et al. Influence of age on the pharmacokinetics of irinotecan (CPT-11) and its metabolites, SN-38 and SN-38 glucuronide (SN-38G) in patients with previously treated colorectal cancer [abstract]. Proc Am Soc Clin Oncol 1997;16:202a.
40. Innocenti F, Ratain MJ. Irinotecan treatment in cancer patients with UGT1A1 polymorphisms. Oncology (Huntingt) 2003;17:52-5.
41. Marsh S, McLeod HL. Pharmacogenetics of irinotecan toxicity. Pharmacogenomics 2004;7:835-43.
42. Meyerhardt JA, Kwok A, Ratain MJ, et al. Relationship of baseline serum bilirubin to efficacy and toxicity of single-agent irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 2004;22:1439-46.
43. Kehrer DF, Yamamoto W, Verweij J, deJonge MJ, de Bruijn P, Sparreboom A. Factors involved in prolongation of the terminal disposition phase of SN-38: clinical and experimental studies. Clin Cancer Res 2000;6:3393-4.
44. Guidance for industry, pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), May 2003.
45. Patel H, Egorin MJ, Remick SC, et al. Comparison of Child-Pugh criteria and NCI organ dysfunction working group criteria for hepatic dysfunction: implications for chemotherapy dosing [abstract]. Proc Am Soc Clin Oncol 2004;22:6051.