Phase I and Pharmacokinetic study of pemetrexed plus cisplatin in chemonaive patients with locally advanced or metastatic malignant pleural mesothelioma or non-small cell lung cancer

Clinical Cancer Research

Volumn 15, Issue 1, 2009, Pages 382-389

  Dickgreber, Nicolas J ^a   Fink, Thomas H ^b   Latz, Jane E ^c   Hossain, Anwar M ^c   Musib, Luna C ^c   Thomas, Michael ^d  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b KLINIKUM NÜRNBERG   (Germany)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; CYANOCOBALAMIN; DEXAMETHASONE; FOLIC ACID; FOLINIC ACID; PEMETREXED;

ADULT; AGED; ANEMIA; AREA UNDER THE CURVE; ARTICLE; BLEEDING; BLOOD TOXICITY; BRONCHOPNEUMONIA; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEARING TEST; HUMAN; INFECTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MALIGNANT MESOTHELIOMA; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PERCEPTION DEAFNESS; PHASE 1 CLINICAL TRIAL; PLEURA MESOTHELIOMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SEPSIS; SIDE EFFECT; SKIN MANIFESTATION; STOMACH ULCER; THROMBOCYTOPENIA; TINNITUS; TREATMENT RESPONSE; VITAMIN SUPPLEMENTATION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DIETARY SUPPLEMENTS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MESOTHELIOMA; MIDDLE AGED; PLATINUM; PLEURAL NEOPLASMS; VITAMINS;

EID: 58949099830     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-08-0128     Document Type: Article

References (24)

1. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003:21: 2636-44.
2. Hanna N, Shepherd FA, Fossella FV, 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 2004:22: 1589-97
3. Scagliotti G, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008:26:3543-51.
4. hodtmann R, Depenbrock H, Dumez H, et al. Clinical and pharmacokinetic phase I study of multitargeted antifolate (LY231514) in combination with cisplatin. J Clin Oncol 1999:17:3009-16.
5. Niyikiza C, Baker SD, Seitz DE, et al. Homocysteine and methylmalonic acid: markers to predict and avoid toxicity from pemetrexed therapy. Mol Cancer Ther 2002:1:545-52.
6. Vogelzang NJ, Emri S, Boyer M, etal. Effectof folic acid and vitamin B12 supplementation on risk-benefit ratio from phase III study of pemetrexed + cisplatin versus cisplatin in malignant pleural mesothelioma [abstract 2644]. Proc Am Soc Clin Oncol 2003:22:657.
7. Niyikiza C. Hanauske AR, Rusthoven JJ, et al. Pemetrexed safety and dosing strategy. Semin Oncol 2002; 29:24-9.
8. Adjei AA. Pemetrexed (ALIMTA), a novel multitar- geted antineoplastic agent. Clin Cancer Res 2004:10: 4276-80s.
9. Scagliotti GV, Shin DM, Kindler HL, et al. Phase II study of pemetrexed with and without folic acid and vitamin B12 as front-line therapy in malignant pleural mesothelioma J Clin Oncol 2003:21:1556-61.
10. Takimoto CH, Hammond-Thelin LA. Latz JE, et al Phase I and pharmacokinetic study of pemetrexed with high-dose folic acid supplementation or multivitamin supplementation in patients with locally advanced or metastatic cancer. Clin Cancer Res 2007:13:2675-83.
11. Nakagawa K, Kudoh S, Matsui K, et al A phase I study of pemetrexed (LY231514) supplemented with folate and vitamin B12 in Japanese patients with solid tumours. Br J Cancer 2006;95:677-82.
12. Cullen MH, Zatloukal P. Sorenson S, et al. A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non- small-cell lung cancer Ann Oncol 2008,19 939-45.
13. 2 of pemetrexed in patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had prior chemotherapy [abstract], J Clin Oncol 2007:25:7590
14. Rinaldi DA. Kuhn JG. Burris HA, et al 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 1999:44 372-80.
15. Latz JE, Chaudhary A, Ghosh A, Johnson RD Population pharmacokinetic analysis of ten phase II clinical trials of pemetrexed in cancer patients Cancer Chemother Pharmacol 2006:57:401 -11
16. Vermorken JB, van der Vijgh WJ, Klein I, et al. Pharmacokinetics of free and total platinum species after short-term infusion of cisplatin. Cancer Treat Rep 1984;68:505-13.
17. Ozer H, Armitage JO, Bennett CL, et al. 2000 update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. American Society of Clinical Oncology Growth Factors Expert Panel. J Clin Oncol 2000;18:3558-85.
18. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16: 31 -41.
19. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment 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 2000;92:205-16.
20. Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol 2004;15:257-60.
21. Urien S, Brain E, Bugat R, et al. Pharmacokinetics of platinum after oral or intravenous cisplatin: a phase 1 study in 32 adult patients. Cancer Chemother Pharmacol 2005;55:55-60.
22. Beal SL, Sheiner LB. NONMEM user's guide. University of California at San Francisco (CA): NONMEM Project Group; 1992.
23. Schellens JH, Ma J, Planting AS, et al. Relationship between the exposure to cisplatin, DNA-adduct formation in leucocytes and tumour response in patients with solid tumours. Br J Cancer 1996;73: 1569-75.
24. Latz J, Claret L, Symanowski J, et al. Evaluation of pemetrexed (PEM) dosing paradigms using exposure-response relationships (ERRs). J Clin Oncol 2007:25:2530.