A phase I study of pemetrexed (LY231514) supplemented with folate and vitamin B12 in Japanese patients with solid tumours

British Journal of Cancer

Volumn 95, Issue 6, 2006, Pages 677-682

  Nakagawa, K ^a   Kudoh, S ^b   Matsui, K ^c   Negoro, S ^d,g   Yamamoto, N ^e   Latz, J E ^f   Adachi, S ^f   Fukuoka, M ^a  

^a KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b OSAKA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c OSAKA PREFECTURAL MEDICAL CENTER FOR RESPIRATORY AND ALLERGIC DISEASES   (Japan)

^d OSAKA CITY GENERAL HOSPITAL   (Japan)

^e SHIZUOKA CANCER CENTER   (Japan)

^f ELI LILLY AND COMPANY   (United States)

^g HYOGO MEDICAL CENTER FOR ADULTS   (Japan)

Author keywords

Antifolate; Lung cancer; Pemetrexed; Pharmacokinetics; Vitamin supplementation

Indexed keywords

ALANINE AMINOTRANSFERASE; CYANOCOBALAMIN; FOLIC ACID; PEMETREXED;

ADULT; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME METABOLISM; ERYTHROPENIA; FATIGUE; FEMALE; FEVER; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MALAISE; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; THYMOMA; TREATMENT RESPONSE; VITAMIN SUPPLEMENTATION; VOMITING;

ADULT; AGED; ALANINE TRANSAMINASE; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLIC ACID; GLUTAMATES; GUANINE; HUMANS; INFUSIONS, INTRAVENOUS; JAPAN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA; SAFETY; TREATMENT OUTCOME; VITAMIN B 12;

EID: 33748565959     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603321     Document Type: Article

References (21)

1. Alati T, Worzalla JF, Shih C, Bewley JR, Lewis S, Moran RG, Grindey GB (1996) Augmentation of the therapeutic activity of lometrexol-(6-R)5,10- dideazatetrahydrofolate- by oral folic acid. Cancer Res 56: 2331-2335
2. Chaudhary AK, Schannen V, Knadler MP (1999) Analysis of LY231514 in plasma and urine using perchloric acid with LC/MS/MS. In Presented at the Proceedings of 47th ASMS Conference on Mass Spectrometry and Allied Topics. Dallas, TX, June 13-17 (abstract)
3. Hammond LA, Forero L, Beeram M, Forouzesh B, De Bono J, Tolcher A, Patnaik A, Monroe P, Clark R, Rowinsky EK (2003) Phase 1 study of pemetrexed (LY231514) with vitamin supplementation in patients with locally advanced or metastatic cancer. Proc Am Soc Clin Oncol 22: 133 (abstract 532)
4. Hanauske A, Chen V, Paoletti P, Niyikiza C (2001) Pemetrexed disodium: a novel antifolate clinically active against multiple solid tumors. Oncologist 6: 363-373
5. Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn Jr PA (2004) Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22: 1589-1597
6. Laohavinij S, Wedge SR, Lind MJ, Bailey N, Humphreys A, Proctor M, Chapman F, Simmons D, Oakley A, Robson L, Gumbrell L, Taylor GA, Thomas HD, Boddy AV, Newell DR, Calvert AH (1996) A phase I clinical study of the antipurine antifolate lometrexol (DDATHF) given with oral folic acid. Invest New Drugs 14: 325-335
7. Latz JE, Chaudhary A, Ghosh A, Johnson RD (2006) Population pharmacokinetic analysis of ten phase II clinical trials of pemetrexed in cancer patients. Cancer Chemother Pharmacol 57: 401-411
8. Maughan TS, James RD, Kerr D, McArdle C, Ledermann JA, Seymour M, Johnston C, Stephens RJ (1999) Preliminary results of a multicentre randomised trial comparing 3 chemotherapy regimens (de Gramont, Lokich and Raltitrexed) in metastatic colorectal cancer. Proc Am Soc Clin Oncol 18: 262a (abstract 1007)
9. McDonald AC, Vasey PA, Adams L, Walling J, Woodworth JR, Abrahams T, McCarthy S, Bailey NP, Siddiqui N, Lind MJ, Calvert AH, Twelves CJ, Cassidy J, Kaye SB (1998) A phase I and pharmacokinetic study of LY231514, the multitargeted antifolate. Clin Cancer Res 4: 605-610
10. Mendelsohn LG, Gates SB, Habeck LL, Shackelford KA, Worzalla J, Shih C, Grindey GB (1996) The role of dietary folate in modulation of folate receptor expression, folylpolyglutamate synthetase activity and the efficacy and toxicity of lometrexol. Adv Enzyme Regul 36: 365-381
11. Morgan SL, Baggott JE, Vaughn WH, Young PK, Austin JV, Krumdieck CL, Alarcon GS (1990) The effect of folic acid supplementation on the toxicity of low-dose methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 33: 9-18
12. Niyikiza C, Baker SD, Seitz DE, Walling JM, Nelson K, Rusthoven JJ, Stabler SP, Paoletti P, Calvert AH, Allen RH (2002a) Homocysteine and methylmalonic acid: markers to predict and avoid toxicity from pemetrexed therapy. Mol Cancer Ther 1: 545-552
13. Niyikiza C, Hanauske A-R, Rusthoven JJ, Calvert AH, Allen R, Paoletti P, Bunn Jr PA (2002b) Pemetrexed safety and dosing strategy. Semin Oncol 29: 24-29
14. Rinaldi DA, Burris HA, Dorr FA, Woodworth JR, Kuhn JG, Eckardt JR, Rodriguez G, Corso SW, Fields SM, Langley C (1995) Initial phase I evaluation of the novel thymidylate synthase inhibitor, LY231514, using the modified continual reassessment method for dose escalation. J Clin Oncol 13: 2842-2850
15. Rinaldi DA, Kuhn JG, Burris HA, Dorr FA, Rodriguez G, Eckhardt SG, Jones S, Woodworth JR, Baker S, Langley C, Mascorro D, Abrahams T, Von Hoff DD (1999) A phase I evaluation of multitargeted antifolate (MTA, LY231514), administered every 21 days, utilizing the modified continual reassessment method for dose escalation. Cancer Chemother Pharmacol 44: 372-380
16. Rosenberg LE, Fenton WA (1989) Disorders of propionate and methylmalonate metabolism. In The Metabolic Basis of Inherited Disease Scriver CR, Sly WL, (eds). 6th edition, pp 821-844. McGraw-Hill: New York
17. Rowland M, Tozer TN (1995) Clinical Pharmacokinetics: Concepts and Applications (ed 3). Lippincott Williams & Wilkins: Baltimore
18. Savage DG, Lindenbaum J, Stabler SP, Allen RH (1994) Sensitivity of serum methylmalonic acid and total homocysteine determinations for diagnosing cobalamin and folate deficiencies. Am J Med 96: 239-246
19. Shih C, Habeck LL, Mendelsohn LG, Chen VJ, Schultz RM (1998) Multiple folate enzyme inhibition: mechanism of a novel pyrrolopyrimidine-based antifolate LY231514 (MTA). Adv Enzyme Regul 38: 135-152
20. Taylor EC, Patel HH (1992) Synthesis of pyrazolo[3,4-d]pyrimidine analogues of the potent antitumor agent N-{4-[2-(2-amino-4(3H)-oxo-7H-pyrrolo[2, 3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamic acid (LY231514). Tetrahedron 48: 8089- 8100
21. Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P (2003) Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21: 2636- 2644