A dose-escalation and pharmacokinetics study of gemcitabine and oxaliplatin in patients with advanced solid tumors

Annals of Oncology

Volumn 14, Issue 2, 2003, Pages 304-312

  Mavroudis, D ^a   Pappas, P ^b   Kouroussis, C ^a   Kakolyris, S ^a   Agelaki, S ^a   Kalbakis, K ^a   Androulakis, N ^a   Souglakos, J ^a   Vardakis, N ^a   Nikolaidou, N ^b   Samonis, G ^a   Marselos, M ^b   Georgoulias, V ^a  

^a UNIVERSITY HOSPITAL OF HERAKLION   (Greece)

^b UNIVERSITY OF IOANNINA   (Greece)

Author keywords

Gemcitabine; Oxaliplatin; Phase I; Solid tumors

Indexed keywords

ANTIEMETIC AGENT; CARBOPLATIN; CISPLATIN; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; GROWTH FACTOR; OXALIPLATIN; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; PLATINUM COMPLEX;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BONE MARROW SUPPRESSION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG HYPERSENSITIVITY; DRUG INFUSION; DRUG TOLERABILITY; DYSESTHESIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUROTOXICITY; NEUTROPENIA; OTOTOXICITY; PARESTHESIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; THROMBOCYTOPENIA; CHEMICALLY INDUCED DISORDER; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; NEOPLASM;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; NEUTROPENIA; ORGANOPLATINUM COMPOUNDS;

EID: 0037293496     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdg063     Document Type: Article

References (32)

1. Heinemann V, Xu YZ, Chubb S et al. Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2′,2′-difluorodeoxycytidine. Mol Pharmacol 1990; 38: 567-572.
2. Huang P, Chubb S, Hertel LW et al. Action of 2′,2′-difluorodeoxycytidine on DNA synthesis. Cancer Res 1991; 51: 6110-6117.
3. Carmichael J. The role of gemcitabine in the treatment of other tumours. Br J Cancer 1998; 78 (Suppl 3): 21-25.
4. Fossella FV, Lippman SM, Shin DM et al. Maximum-tolerated dose defined for single-agent gemcitabine: a phase I dose-escalation study in chemotherapy-naive patients with advanced non-small-cell lung cancer. J Clin Oncol 1997; 15: 310-316.
5. Green M. Gemcitabine safety overview. Semin Oncol 1996; 23 (Suppl 10): 32-35.
6. Raymond E, Faivre S, Woynarowski J et al. Oxaliplatin: mechanism of action and antineoplastic activity. Semin Oncol 1998; 25 (Suppl 5): 4-12.
7. Chollet P, Bensmaine A, Brienza S et al. Single agent activity of oxaliplatin in heavily pretreated advanced epithelial ovarian cancer. Ann Oncol 1996; 7: 1065-1070.
8. Rixe O, Ortuzar W, Alvarez M et al. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: Spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institute's Anticancer Drug Screen panel. Biochem Pharmacol 1996; 52: 1855-1865.
9. Bleiberg H. Oxaliplatin (L-OHP): a new reality in colorectal cancer. Br J Cancer 1998; 77 (Suppl 4): 1-3.
10. Cvitkovic E. Ongoing and unsaid on oxaliplatin: the hope. Br J Cancer 1998; 77 (Suppl 4): 8-11.
11. Extra JM, Marty M, Brienza S et al. Pharmacokinetics and safety profile of oxaliplatin. Semin Oncol 1998; 25 (Suppl 5): 13-22.
12. Extra JM, Espie M, Calvo F et al. Phase I study of oxaliplatin in patients with advanced cancer. Cancer Chemother Pharmacol 1990; 25: 299-303.
13. Faivre S, Raymond E, Woynarowski JM et al. Supraadditive effect of 2′,2′-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol 1999; 44: 117-123.
14. Miller AB, Hoogstraten BB, Staquet M et al. Reporting results of cancer treatment. Cancer 1981; 47: 207-214.
15. Abbruzzese JL, Grunewald R, Weeks EA et al. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol 1991; 9: 491-498.
16. Massari C, Brienza S, Rotarski M et al. Pharmacokinetics of oxaliplatin in patients with normal versus impaired renal function. Cancer Chemother Pharmacol 2000; 45: 157-164.
17. Wasserman E, Cuvier C, Lokiec F et al. Combination of oxaliplatin plus irinotecan in patients with gastrointestinal tumors: results of two independent phase I studies with pharmacokinetics. J Clin Oncol 1999; 17: 1751-1759.
18. Grunewald R, Kantarjian H, Du M et al. Gemcitabine in leukemia: a phase I clinical, plasma, and cellular pharmacology study. J Clin Oncol 1992; 10: 406-413.
19. Kern W, Braess J, Bottger B et al. Oxaliplatin pharmacokinetics during a four-hour infusion. Clin Cancer Res 1999; 5: 761-765.
20. Mavroudis D, Kourousis Ch, Kakolyris S et al. Phase I study of the gemcitabine/oxaliplatin combination in patients with advanced solid tumors: a preliminary report. Semin Oncol 2000; 27 (1 Suppl 2): 25-30.
21. Misset JL, Chollet PH, Vennin PH et al. Multicentric phase II-III trial of oxaliplatin versus cisplatin both in association with cyclophosphamide in the treatment of advanced ovarian cancer: Toxicity, efficacy results. Proc Am Soc Clin Oncol 1997; 16: 354a (Abstr 1266).
22. Graham M, Lockwood G, Greenslade D et al. Clinical pharmacokinetics of oxaliplatin: a critical review. Clin Cancer Res 2000; 6: 1205-1218.
23. Garufi C, Nistico C, Brienza S et al. Single-agent oxaliplatin in pre-treated advanced breast cancer: a phase II study. Ann Oncol 2001; 12: 179-182.
24. Shapiro JD, Millward MJ, Rischin D et al. Activity of gemcitabine in patients with advanced ovarian cancer: responses seen following platinum and paclitaxel. Gynecol Oncol 1996; 63: 89-93.
25. Piccart MJ, Green JA, Lacave AJ et al. Oxaliplatin or paclitaxel in patients with platinum-pretreated ovarian cancer: a randomised phase II study of the European Organization for Research and Treatment of Cancer Gynecology Group. J Clin Oncol 2000; 18: 1193-1202.
26. Lorusso V, Pollera CF, Antimi M et al. A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Eur J Cancer 1998; 34: 1208-1212.
27. Einhorn LH, Stender MJ, Williams SD. Phase II trial of gemcitabine in refractory germ cell tumors. J Clin Oncol 1999; 17: 509-511.
28. Germann N, Brienza S, Rotarski M et al. Preliminary results on the activity of oxaliplatin (L-OHP) in refractory/recurrent non-Hodgkin's lymphoma patients. Ann Oncol 1999; 10: 351-354.
29. Monnet I, Brienza S, Hugret F et al. Phase II study of oxaliplatin in poor-prognosis non-small cell lung cancer (NSCLC). Eur J Cancer 1998; 37: 1124-1127.
30. Nehme A, Baskaran R, Nebel S et al. Induction of JNK and c-Abl signalling by cisplatin and oxaliplatin in mismatch repair-proficient and -deficient cells. Br J Cancer 1999; 79: 1104-1110.
31. Raymond E, Lawrence R, Izbicka E et al. Activity of oxaliplatin against human tumor colony-forming units. Clin Cancer Res 1998; 4: 1021-1029.
32. Louvet C, Andre T, Lledo G et al. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol 2002; 20: 1512-1518.