Administration of pemetrexed immediately following gemcitabine as front-line therapy in advanced non-small cell lung cancer: A phase II trial

Lung Cancer

Volumn 53, Issue 1, 2006, Pages 77-83

  Treat, Joseph ^a   Bonomi, Philip ^b   McCleod, Michael ^c   Christiansen, Neal P ^d   Mintzer, David M ^e   Monberg, Matthew J ^a   Ye, Zhishen ^a   Chen, Ruqin ^a   Obasaju, Coleman K ^a  

^a ELI LILLY AND COMPANY   (United States)

^b RUSH MEDICAL COLLEGE   (United States)

^c Florida Cancer Specialists   (United States)

^d SC Oncology Associates   (United States)

^e PENNSYLVANIA HOSPITAL   (United States)

Author keywords

Gemcitabine; Immediate administration; NSCLC; Pemetrexed

Indexed keywords

CYANOCOBALAMIN; FOLIC ACID; GEMCITABINE; PEMETREXED; STEROID;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG EFFICACY; DRUG FEVER; DRUG INFUSION; DRUG RESPONSE; DYSPNEA; EARLY INTERVENTION; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; RASH; STOMATITIS; SURVIVAL RATE; THORAX PAIN; THROMBOCYTOPENIA; VOMITING;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; DEOXYCYTIDINE; DISEASE PROGRESSION; FEMALE; GLUTAMATES; GUANINE; HUMANS; INFUSIONS, INTRAVENOUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 33744815626     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2006.04.005     Document Type: Article

References (32)

1. Pisani P., Parkin D.M., Bray F., and Ferlay J. Estimates of the worldwide mortality from 25 cancers in 1990. Int J Cancer 83 6 (1999) 18-29
2. Shepherd F.A. Screening, diagnosis, and staging of lung cancer. Curr Opin Oncol 5 2 (1993) 310-322
3. Walling J. Chemotherapy for advanced non-small-cell lung cancer. Respir Med 88 9 (1994) 649-657
4. Schiller J.H., Harrington D., Belani C.P., Langer C., Sandler A., Krook J., et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346 2 (2002) 92-98
5. Scagliotti G.V., De Marinis F., Rinaldi M., Crino L., Gridelli C., Ricci S., et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20 21 (2002) 4285-4291
6. Treat J., Belani C., Edelman M., Socinski M., Ansari R., Obasaju C., et al. A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (stage IIIB, IV) Non-Small Cell Lung Cancer (NSCLC): update of the Alpha Oncology trial (A1-99002L). Proc Am Soc Clin Oncol 23 (2005) 7025 (abstract)
7. Mendelsohn L.G., Shih C., Chen V.J., Habeck L.L., Gates S.B., and Shackelford K.A. Enzyme inhibition, polyglutamation, and the effect of LY231514 (MTA) on purine biosynthesis. Semin Oncol 26 2 Suppl 6 (1999) 42-47
8. Schultz R.M., Chen V.J., Bewley J.R., Roberts E.F., Shih C., and Dempsey J.A. Biological activity of the multitargeted antifolate, MTA (LY231514), in human cell lines with different resistance mechanisms to antifolate drugs. Semin Oncol 26 2 Suppl 6 (1999) 68-73
9. Cripps C., Burnell M., Jolivet J., Batist G., Lofters W., Dancey J., et al. Phase II study of first-line LY231514 (multi-targeted antifolate) in patients with locally advanced or metastatic colorectal cancer: an NCIC Clinical Trials Group study. Ann Oncol 10 10 (1999) 1175-1179
10. Kindler H.L. Pemetrexed in pancreatic cancer. Semin Oncol 29 6 Suppl 18 (2002) 49-53
11. O'Shaughnessy J.A., Clark R.S., Blum J.L., Mennel R.G., Snyder D., Ye Z., et al. Phase II study of pemetrexed in patients pretreated with an anthracycline, a taxane, and capecitabine for advanced breast cancer. Clin Breast Cancer 6 2 (2005) 143-149
12. Paz-Ares L., Ciruelos E., Garcia-Carbonero R., Castellano D., Lopez-Martin A., and Cortes-Funes H. Pemetrexed in bladder, head and neck, and cervical cancers. Semin Oncol 29 6 Suppl 18 (2002) 69-75
13. Spielmann M., Martin M., Namer M., duBois A., Unger C., and Dodwell D.J. Activity of pemetrexed (ALIMTA, multitargeted antifolate, LY231514) in metastatic breast cancer patients previously treated with an anthracycline and a taxane: an interim analysis. Clin Breast Cancer 2 1 (2001) 47-51
14. Thodtmann R., Sauter T., Weinknecht S., Weissbach L., Blatter J., Ohnmacht U., et al. A phase II trial of pemetrexed in patients with metastatic renal cancer. Invest New Drugs 21 3 (2003) 353-358
15. Vogelzang N.J., Rusthoven J.J., Symanowski J., Denham C., Kaukel E., Ruffie P., et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21 14 (2003) 2636-2644
16. Hanna N., Shepherd F.A., Fossella F.V., Pereira J.R., De Marinis F., von Pawel J., et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22 9 (2004) 1589-1597
17. Niyikiza C., Baker S.D., Seitz D.E., Walling J.M., Nelson K., Rusthoven J.J., et al. Homocysteine and methylmalonic acid: markers to predict and avoid toxicity from pemetrexed therapy. Mol Cancer Ther 1 7 (2002) 545-552
18. Plunkett W., Huang P., and Gandhi V. Preclinical characteristics of gemcitabine. Anticancer Drugs 6 Suppl 6 (1995) 7-13
19. Gatzemeier U., Shepherd F.A., Le Chevalier T., Weynants P., Cottier B., Groen H.J., et al. Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study. Eur J Cancer 32A 2 (1996) 243-248
20. Manegold C., Bergman B., Chemaissani A., Dornoff W., Drings P., Kellokumpu-Lehtinen P., et al. Single-agent gemcitabine versus cisplatin-etoposide: early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer. Ann Oncol 8 6 (1997) 525-529
21. Teicher B.A., Chen V., Shih C., Menon K., Forler P.A., Phares V.G., et al. Treatment regimens including the multitargeted antifolate LY231514 in human tumor xenografts. Clin Cancer Res 6 3 (2000) 1016-1023
22. Tonkinson J.L., Worzalla J.F., Teng C.H., and Mendelsohn L.G. Cell cycle modulation by a multitargeted antifolate, LY231514, increases the cytotoxicity and antitumor activity of gemcitabine in HT29 colon carcinoma. Cancer Res 59 15 (1999) 3671-3676
23. Adjei A.A., Erlichman C., Sloan J.A., Reid J.M., Pitot H.C., Goldberg R.M., et al. Phase I and pharmacologic study of sequences of gemcitabine and the multitargeted antifolate agent in patients with advanced solid tumors. J Clin Oncol 18 8 (2000) 1748-1757
24. Ma C.X., Nair S., Thomas S., Mandrekar S.J., Nikcevich D.A., Rowland K.M., et al. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer. J Clin Oncol 23 25 (2005) 5929-5937
25. Monnerat C., Le Chevalier T., Kelly K., Obasaju C.K., Brahmer J., Novello S., et al. Phase II study of pemetrexed-gemcitabine combination in patients with advanced-stage non-small cell lung cancer. Clin Cancer Res 10 16 (2004) 5439-5446
26. Dy G.K., Suri A., Reid J.M., Sloan J.A., Pitot H.C., Alberts S.R., et al. A phase IB study of the pharmacokinetics of gemcitabine and pemetrexed, when administered in rapid sequence to patients with advanced solid tumors. Cancer Chemother Pharmacol 55 6 (2005) 522-530
27. Cockcroft D.W., and Gault M.H. Prediction of creatinine clearance from serum creatinine. Nephron 16 1 (1976) 31-41
28. Therasse P., Arbuck S., and Eisenhauer E. New guidelines to evaluate the response to treatement in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92 (2000) 205-216
29. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10 1 (1989) 1-10
30. Kaplan E., and Meier P. Nonparametric estimation of incomplete observations. J Am Stat Assoc 53 (1958) 457-481
31. Trotti A., Byhardt R., Stetz J., Gwede C., Corn B., Fu K., et al. Common toxicity criteria: version 2.0 an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys 47 1 (2000) 13-47
32. Johnson D.H. Evolution of cisplatin-based chemotherapy in non-small cell lung cancer: a historical perspective and the eastern cooperative oncology group experience. Chest 117 4 Suppl 1 (2000) 133S-137S