Gemcitabine: Safety profile unaffected by starting dose

International Journal of Clinical Pharmacology Research

Volumn 16, Issue 1, 1996, Pages 9-18

  Martin, C ^a   Pollera, C F ^b  

^a ELI LILLY AND COMPANY   (United States)

^b Division of Medical Oncology I   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; GEMCITABINE; HEMOGLOBIN;

ARTICLE; CANCER; CONSCIOUSNESS DISORDER; CONSTIPATION; DIARRHEA; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; EDEMA; FEVER; FLU LIKE SYNDROME; GINGIVITIS; HAIR LOSS; HEART ARRHYTHMIA; HEART DISEASE; HEMATOLOGIC DISEASE; HEMATURIA; HUMAN; INFECTION; LEUKOCYTE COUNT; LIVER DYSFUNCTION; LIVER TOXICITY; LUNG TOXICITY; MAJOR CLINICAL STUDY; NAUSEA; NEPHROTOXICITY; NEUTROPHIL; PAIN; PERICARDITIS; PERIPHERAL NEUROPATHY; PROTEINURIA; THROMBOCYTE COUNT; VOMITING;

ANTIMETABOLITES, ANTINEOPLASTIC; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS, PHASE II; DEOXYCYTIDINE; ENZYME INHIBITORS; HUMANS; KIDNEY FUNCTION TESTS; LIVER FUNCTION TESTS; LUNG NEOPLASMS; NAUSEA; PANCREATIC NEOPLASMS; RIBONUCLEOTIDE REDUCTASES; VOMITING;

EID: 0030456669     PISSN: 02511649     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (26)

1. Grindey G.G. et al. Antitumor activity of 2′,2′-difluorodeoxycytidine (LY188011). Proc. Am. Assoc. Cancer Res., 27, 296, 1986 (abstract 1775).
2. Chubb S. et al. Metabolism and action of 2′,2′-difluorodeoxycytidine (dFdC) in human leukemia cell. Proc. Am. Assoc. Cancer Res., 28, 324, 1987 (abstract 1282).
3. Bhalla K. et al. Continuously administered 2′,2′-difluorodeoxycytidine (dFdC) and deoxycytidine (dCyd): a potentially selective cytotoxic regimen toward human leukemic myeloid progenitors in culture. Proc. Am. Assoc. Cancer Res., 28, 348, 1988 (abstract 1385)
4. Fujita F. et al. Effects of a new anticancer agent, LY188011 on human cancer xenografts in nude mice. Forty-eighth Annual Meeting of the Japanese Cancer Association, Nagoya, Japan. October 23 to 25, 1989 (abstract 1938).
5. Tanayanagi C. et al. Action mechanism of difluorodeoxycytidine (dFdC), a new ara-C derivative. Acta Hematol. Jpn., 53, 76, 1990 (abstract 132).
6. Bouffard D.Y., Momparler L.F., Momparler R.L. Comparison of antineoplastic activity of cytosine arabinoside and 2′,2′-difluorodeoxycytidine on human myeloid, T-cell and B-cell leukemic cells. Eur. J. Pharmacol., 183, 161, 1990 (abstract 32).
7. Plunkett W. et al. Increased cytotoxicity and therapeutic activity of 2′,2′-difluorodeoxycytidine over cytosine arabinoside (ara-C) in L1210 leukemia. Proc. Am. Assoc. Cancer Res., 29, 352, 1988 (abstract 1402).
8. Andersen H. et al. Single-agent activity of weekly gemcitabine in advanced non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12, 1821-1826, 1994.
9. Gatzemeier U. et al. A multicenter phase II trial with gemcitabine in non-small cell lung cancer (NSCLC). Lung Cancer II (Suppl. 1). 121, 1994 (abstract 461).
10. Kaye S.B. Gemcitabine current status of phase I and II trials. J. Clin. Oncol., 12, 1527-1531, 1994.
11. Abratt R.P. et al. Efficacy and safety of gemcitabine in non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12, 1535-1540, 1994.
12. Carmichael J. et al. Phase II study of gemcitabine in patients with advanced pancreatic cancer. Eur. J. Cancer, 29A, S101, 1993 (suppl. 6, abstract 541).
13. Casper E.S. et al. Phase II trial of gemcitabine (2′,2′-difluorodeoxycytidine) in patients with adenocarcinoma of the pancreas. Invest. New Drugs, 12, 29-34, 1994.
14. Lund B. et al. Phase II study of gemcitabine (2′,2′-difluorodeoxycytidine) in previously treated ovarian cancer. J. Natl. Cancer Inst. 86, 1530-1533, 1994.
15. Carmichael J. et al. Advanced breast cancer: a phase II trial with gemcitabine. J. Clin. Oncol. (in press).
16. Cormier Y. et al. Gemcitabine is an active new agent in previously un-treated extensive small cell lung cancer. A study of the National Cancer Institute of Canada Clinical Treatment Group. Ann. Oncol., 5, 283-285, 1994.
17. Rollers C.F., Ceribelli A., Crecco M., Calabresi F. Weekly gemcitabine in advanced bladder cancer: a preliminary report from a phase I study. Ann. Oncol., 5, 182-184, 1994.
18. Catimel G. et al. A phase II study of gemcitabine (LY188011) in patients with advanced squamous cell carcinoma of the head and neck. Ann. Oncol., 5, 543-547, 1994.
19. Weissbach L. et al. Phase II study of gemcitabine in renal cancer. Proc Am. Soc. Clin. Oncol. II.219. 1992 (abstract 689).
20. Merterns W.C. et al. Gemcitabine in advanced renal cell carcinoma. A phase II study of the National Cancer Institute of Canada Clinical Trials group. Ann. Oncol., 4, 331-332, 1994.
21. Walling J. Chemotherapy of advanced non-small cell lung cancer. Respir. Med., 88, 649-657, 1994.
22. Blijhan G.H. Prevention and treatment of organ toxicity during high-dose chemotherapy: an overview. Anti-cancer Drugs, 4, 527-533, 1993
23. Abbruzzese J.L. et al. A phase II trial of gemcitabine in patients with advanced colorectal cancer. Proc. Am. Soc. Clin. Oncol., 10, 456, 1991
24. Christman K., Kelsen D., Saltz L., Tarassoff P.G. Phase II trial of gemcitabine in patients with advanced gastric cancer Cancer. 73, 5-7, 1994.
25. Pollera C.F., Ceribelli A., Crecco M., Calabresi F. Weekly gemcitabine in advanced or metastatic solid tumours: a clinical phase I study. Investigational New Drugs, 12, 111-119, 1994.
26. Gatzemeier U., Martin C. Gemcitabine safety profile not compromised by previous chemotherapy. Ann. Oncol., 5 (Suppl 8). 185, (abstr. 936).