Edatrexate (10-ethyi-deaza-aminopterin) (NSC 626715) with or without leucovorin rescue for malignant mesothelioma: Sequential Phase II trials by the Cancer and Leukemia Group B

Cancer

Volumn 86, Issue 10, 1999, Pages 1985-1991

  Kindler, Hedy L ^a   Belani, Chandra P ^b   Herndon II, James E ^c   Vogelzang, Nicholas J ^a   Suzuki, Yasunosuke ^d   Green, Mark R ^e  

^a UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^b UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^c CALGB Statistical Center   (United States)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

Chemotherapy; Edatrexate; Leucovorin; Malignant mesothelioma

Indexed keywords

EDATREXATE; FOLINIC ACID; AMINOPTERIN; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MALIGNANT MESOTHELIOMA; MUCOSA INFLAMMATION; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; TREATMENT OUTCOME; DOSE RESPONSE; LEUKEMIA; MESOTHELIOMA; MIDDLE AGED; MORTALITY; PLEURA TUMOR; SURVIVAL RATE; TREATMENT FAILURE;

AMINOPTERIN; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LEUCOVORIN; LEUKEMIA; MALE; MESOTHELIOMA; MIDDLE AGED; PLEURAL NEOPLASMS; SURVIVAL RATE; TREATMENT FAILURE;

EID: 0033570372     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(19991115)86:10<1985::AID-CNCR15>3.0.CO;2-H     Document Type: Article

References (31)

1. Wagner JC, Slegg CA, Marchand P. Diffuse pleural mesothelioma and asbestos exposure in Northwestern Cape Province. Br J Ind Med 1960;17:260-71.
2. Price B. Analysis of current trends in United States mesothelioma incidence. Am J Epidemiol 1997;145:211-8.
3. Ong ST, Vogelzang NJ. Chemotherapy in malignant pleural mesothelioma: a review. J Clin Oncol 1996;14:1007-17.
4. Aisner J, Wiernik PH. Chemotherapy in the treatment of malignant mesothelioma. Semin Oncol 1981;8:335-43.
5. Kindler HL, Vogelzang NJ. Mesothelioma. In: Yokes EE, Golomb HM, editors. Oncologic therapies. Berlin: Springer-Verlag, 1999:635-51.
6. Solheim OP, Saeter G, Finnanger AM, Stenwig AE. High-dose methotrexate in the treatment of malignant mesothelioma of the pleura. A phase II study. Br J Cancer 1992;65: 956-60.
7. Dimitrov NV, Egner J, Balcueva E, Suhrland LG. High-dose methotrexate with citrovorum factor and vincristine in the treatment of malignant mesothelioma. Cancer 1982;50: 1245-47.
8. Vogelzang NJ, Weissmann LB, Herndon JE, Antman KH, Cooper MR, Corson JM, et al. Trimetrexate in malignant mesothelioma: a Cancer and Leukemia Group B phase II study. J Clin Oncol 1994;12:1436-42.
9. Sirotnak FM, DeGraw JI, Moccio DM, Samuels LL, Goutas LJ. New folate analogs of the 10-deza-aminopterin series. Basis for structural design and biochemical and pharmacologic properties. Cancer Chemother Pharmacol 1984;12:18-25.
10. Sirotnak FM, DeGraw JI, Schmid FA, Goutas LJ, Moccio DM. New folate analogs of the 10-deaza-aminopterin series. Further evidence for markedly increased antitumor efficacy compared with methotrexate in ascitic and solid tumor murine models. Cancer Chemother Pharmacol 1984;12:26-30.
11. Sirotnak FM, Otter GM, Schmid FA. Markedly improved efficacy of edatrexate compared to methotrexate in a high-dose regimen with leucovorin rescue against metastatic murine solid tumors. Cancer Res 1993;53:587-91.
12. Schmid FA, Sirotnak FM, Otter M, DeGraw JI. New folate analogs of the 10-deaza-aminopterin series: markedly increased antitumor activity of the 10-Ethyl analog compared to the parent compound and methotrexate against some human tumor xenografts in nude mice. Cancer Treat Rep 1985;69:551-53.
13. Takimoto C, Allegra CJ. New antifolates in clinical development. Oncology 1995;9:649-59.
14. Kris MG, Kinahan JJ, Gralla RJ, Fanucchi MP, Wertheim MS, O'Connell JP, et al. Phase 1 trial and clinical pharmacological evaluation of 10-Ethyl-10-deazaaminopterin in adult patients with advanced cancer. Cancer Res 1988;48:5573-9.
15. Grant SC, Kris MG, Young CW, Sirotnak FM. Edatrexate, an antifolate with antitumor activity: a review. Cancer Invest 1993;11:36-45.
16. Shum KY, Kris MG, Gralla RJ, Burke MT, Marks LD, Heelan RT. Phase II study of 10-Ethyl-10-deaza-aminopterin in patients with stage III and IV non-small cell lung cancer. J Clin Oncol 1988;6:446-50.
17. Jolivet J, Jansen G, Peters GJ, Pinard M-F, Schornagel JH. Leucovorin rescue of human cancer and bone marrow cells following edatrexate or methotrexate. Biochem Pharmacol 1994;47:659-65.
18. Lee JS, Murphy WK, Shirinian MH, Pang A, Hong WK. Alleviation by leucovorin of the dose-limiting toxicity of edatrexate: potential for improved therapeutic efficacy. Cancer Chemother Pharmacol 1991;28:199-204.
19. Vogelzang NJ, Herndon JE, Cirrincione C, Harmon DC, Antman KH, Corson JM, et al. Dihydro-5-azacytidine in malignant mesothelioma: a phase II trial demonstrating activity accompanied by cardiac toxicity. Cancer 1997;79:2237-42.
20. Chahinian AP, Antman K, Goutsou M, Corson JM, Suzuki Y, Modeas C, et al. Randomized phase II trial of cisplatin with mitomycin or doxorubicin for malignant mesothelioma by the Cancer and Leukemia Group B. J Clin Oncol 1993;8: 1559-65.
21. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10.
22. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
23. Lerner HJ, Schoenfeld DA, Martin A, Falkson G, Borden E. Malignant mesothelioma: the Eastern Cooperative Oncology Group (ECOG) experience. Cancer 1983;52:1981-5.
24. Raghavan D, Gianoutsos P, Bishop J, Lee J, Young I, Corte P, et al. Phase II trial of carboplatin in the management of mesothelioma. J Clin Oncol 1990;8:151-4.
25. Rusch VW. A proposed new international TNM staging system for malignant pleural mesothelioma from the International Mesothelioma Interest Group. Lung Cancer 1996; 14: 1-12.
26. Herndon JE, Green MR, Chahinian AP, Corson JP, Suzuki Y, Vogelzang NJ. Factors predictive of survival among 337 patients with mesothelioma treated between 1984 and 1994 by the Cancer and Leukemia Group B. Chest 1998;113:723-31.
27. Thoedtmann R, Kemmerich M, Depenbrock H, Blatter J, Ohnmacht U, Hanauske A-R. A phase 1 study of MTA (Multitargeted Antifolate, LY231514) plus cisplatin in patients with advanced solid tumors. Proc Am Soc Clin Oncol 1998; 17:254a.
28. Perez EA, Whittal D, Hesketh PJ. Phase I trial of biweekly edatrexate in breast cancer. Proc Am Soc Clin Oncol 1994; 13:59.
29. Grunberg SM, Spears CP, Jeliffe RW, Zaretsky S, Shahinian AH, Su S, et al. Phase I clinical and pharmacokinetic (PK) study of high-dose edatrexate (EDX) with leucovorin (LV) rescue (Protocol NCI-T91-0077) Proc Am Soc Clin Oncol 1993;12:154.
30. Wan SH, Huffman DH, Azarnoff DL, Stephens R, Hoogstraten B. Effect of route of administration and effusions on methotrexate pharmacokinetics. Cancer Res 1974;34:3487-91.
31. Gandara DR, Edelman MJ, Crowley JJ, Lau DHM, Livingston RB. Phase II trial of edatrexate plus carboplatin in metastatic non-small cell lung cancer: a Southwest Oncology Group study. Cancer Chemother Pharmacol 1997;41:75-8.