Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer

Investigational New Drugs

Volumn 26, Issue 4, 2008, Pages 339-345

  Stover, Daniel G ^a   Lockhart, A Craig ^b   Berlin, Jordan D ^b   Chan, Emily ^b   Sandler, Alan B ^b   Sosman, Jeffery A ^b   Middlebrook, Victoria ^c   Nicol, Steven ^c   Rothenberg, MacE L ^b  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VANDERBILT INGRAM CANCER CENTER   (United States)

^c ELI LILLY AND COMPANY   (United States)

Author keywords

ALIMTA ; Clinical trial; Oxaliplatin; Pemetrexed; Phase I

Indexed keywords

CYANOCOBALAMIN; DEXAMETHASONE; FOLINIC ACID; OXALIPLATIN; PEMETREXED;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADENOCARCINOMA; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BILE DUCT CARCINOMA; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DESQUAMATION; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG SAFETY; ESOPHAGUS CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLATULENCE; GALLBLADDER CANCER; HEAD AND NECK CARCINOMA; HUMAN; HYPONATREMIA; KIDNEY CANCER; LEUKOPENIA; LUNG CANCER; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVARY CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; RECTUM HEMORRHAGE; SALIVARY GLAND CANCER; SENSORY NEUROPATHY; SIDE EFFECT; SQUAMOUS CELL CARCINOMA; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; DOSE-RESPONSE RELATIONSHIP, DRUG; FATIGUE; FEMALE; GLUTAMATES; GUANINE; HEAD AND NECK NEOPLASMS; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM METASTASIS; NEUTROPENIA; ORGANOPLATINUM COMPOUNDS;

EID: 45849106843     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-008-9133-4     Document Type: Article

References (20)

1. Grindey GBSC, Barnett CJ et al (1992) LY231514, a novel pyrrolopyrimidine antifolate that inhibits thymidylate synthase (TS) [Abstract 2451]. Proc Am Assoc Cancer Res 33:411
2. Shih CGG, Barnett CJ et al (1992) Structure-activity relationship studies of novel pyrrolopyrimidine antifolate LY231514 [Abstract 2452]. Proc Am Assoc Cancer Res 33:411
3. Chen VJBJ, Gossett L (1996) Activity of LY231514 against several enzymes in the folate-dependent pathways [Abstract 2598]. Proc Am Assoc Cancer Res 37:381
4. Hanauske AR, Chen V, Paoletti P, Niyikiza C (2001) Pemetrexed disodium: a novel antifolate clinically active against multiple solid tumors. Oncologist 6:363-373
5. Adjei AA (2004) Pemetrexed (ALIMTA), a novel multitargeted antineoplastic agent. Clin Cancer Res 10:4276s-4280s
6. Fink D, Nebel S, Aebi S et al (1996) The role of DNA mismatch repair in platinum drug resistance. Cancer Res 56:4881-4886
7. Teicher BA, Chen V, Shih C et al (2000) Treatment regimens including the multitargeted antifolate LY231514 in human tumor xenografts. Clin Cancer Res 6:1016-1023
8. Raymond E, Louvet C, Tournigand C et al (2002) Pemetrexed disodium combined with oxaliplatin, SN38, or 5-fluorouracil, based on the quantitation of drug interactions in human HT29 colon cancer cells. Int J Oncol 21:361-367
9. Misset JL, Gamelin E, Campone M et al (2004) Phase I and pharmacokinetic study of the multitargeted antifolate pemetrexed in combination with oxaliplatin in patients with advanced solid tumors. Ann Oncol 15:1123-1129
10. Therasse P, Arbuck SG, Eisenhauer EA et al (2000) 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 92:205-216
11. Oken MM, Creech RH, Tormey DC et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655
12. Misset JL, Bleiberg H, Sutherland W et al (2000) Oxaliplatin clinical activity: a review. Crit Rev Oncol Hematol 35:75-93
13. Rinaldi DA, Burris HA, Dorr FA et al (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
14. Atkins JN, Jacobs SA, Wieand HS et al (2005) Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer: a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program. Clin Colorectal Cancer 5:181-187
15. Scagliotti GV, Kortsik C, Dark GG et al (2005) Pemetrexed combined with oxaliplatin or carboplatin as first-line treatment in advanced non-small cell lung cancer: a multicenter, randomized, phase II trial. Clin Cancer Res 11:690-696
16. Pasetto LM, D'Andrea MR, Rossi E, Monfardini S (2006) Oxaliplatin-related neurotoxicity: how and why. Crit Rev Oncol Hemato l59:159-168
17. Pivot X, Raymond E, Laguerre B et al (2001) Pemetrexed disodium in recurrent locally advanced or metastatic squamous cell carcinoma of the head and neck. Br J Cancer 85:649-655
18. Paz-Ares L, Ciruelos E, Garcia-Carbonero R et al (2002) Pemetrexed in bladder, head and neck, and cervical cancers. Semin Oncol 29:69-75
19. Espinosa M, Martinez M, Aguilar JL et al (2005) Oxaliplatin activity in head and neck cancer cell lines. Cancer Chemother Pharmacol 55:301-305
20. Degardin M, Cappelaere P, Krakowski I et al (1996) Phase II trial of oxaliplatin (L-OHP) in advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer B Oral Oncol 32B:278-279