A phase I study of a 24 hour infusion of gemcitabine in previously untreated patients with inoperable non-small-cell lung cancer

British Journal of Cancer

Volumn 74, Issue 3, 1996, Pages 460-462

  Anderson, H ^a,d   Thatcher, N ^a   Walling, J ^b   Hansen, H ^c  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b ELI LILLY AND COMPANY   (United States)

^c Rigshospitalet   (Denmark)

^d WYTHENSHAWE HOSPITAL   (United Kingdom)

Author keywords

24 h infusion; Gemcitabine; Non small cell lung cancer; Phase I study

Indexed keywords

ACICLOVIR; ANTIEMETIC AGENT; GEMCITABINE;

ADULT; AGED; ARTICLE; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG TOXICITY; FEMALE; FEVER; HERPES; HUMAN; HYPOTENSION; LETHARGY; LEUKOPENIA; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM PERMISSIBLE DOSE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; VOMITING;

EID: 0030035730     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/bjc.1996.382     Document Type: Article

References (13)

1. ABBRUZZESE JL, GRUNEWALD R, WEEKS EA, GRAVEL D, ADAMS T, NOWAK B, MINEISHI S, TARASSOFF P, SATTERLEE W AND RABNER NM. (1991). A phase I clinical, plasma and cellular pharmacology study of gemcitabine. J. Clin. Oncol., 9, 491 498.
2. ABRATT RP, BEZWODA WR, FALKSON G, GOEDHALS L, HACKING D AND RUGG TA. (1994). Efficacy and safety profile of gemcitabine in non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12, 1535-1540.
3. ANDERSON H, LUND B, BACH F, THATCHER N, WALLING J AND HANSEN HH. (1994). Single agent activity of weekly Gemcitabine in advance non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12, 1821 1826.
4. CPMP WORKING PARTY ON EFFICACY OF MEDICINAL PRODUCTS. (1990). EEC note for guidance: good clinical practice for trials on medicinal products in the European Community. Pharmacol. Toxicol., 67, 361 372.
5. HEINEMANN V, HERTEL LW, GRINDEY GB AND PLUNKETT W. (1988). Comparison of the cellular pharmacokinetics and toxicity of 2′ 2′ difluorodeoxycytidine and 1-B-D-arabinofuranosylcytosine. Cancer Res., 48, 4024-2031.
6. HERTEL LW, BODER GB, KROIN JS, RINZEL SM, POORE GA, TODD GC AND GRINDEY GB. (1990). Evaluation of the antitumour activity of gemcitabine (2′, 2′-difluoro-2′-deoxycytidine). Cancer Res., 50, 4417-4422.
7. HUANG P, CHUBB S, HERTEL LW, GRINDEY GB AND PLUNKETT W. (1991). Action of 2′2′ difluorodeoxycytidine on DNA synthesis. Cancer Res., 51, 6110-6117.
8. MILLER AB, HOOGSTRATEN B, STAQUET M AND WINKLER A. (1981). Reporting the results of cancer treatment. Cancer, 47, 207 214.
9. MOUNTAIN CF. (1986). A new international staging system for lung cancer. Chest, 89, (suppl.) 225 233.
10. O'ROURKE TJ, BROWN TD, HAVLIN K, KUHN JG, CRAIG JB, BURRIS HA, SATTERLEE WG, TARASSOFF PG AND VON HOFF DD. (1994). Phase I clinical trial of gemcitabine given as an intravenous bolus on 5 consecutive days. Eur. J. Cancer, 30A, 417 418.
11. POPLIN EA, CORBETT T, FLAHERTY L, TARASOFF P, REDMAN BG, VALDIVIESO M AND BAKER L. (1992). Difluorodeoxycytidine (dFdC) gemcitabine: a phase I study. Invest. New Drugs, 10, 165 170.
12. VEERMAN G, RUIZ VAN HAPEREN V AND VERMORKEN JB. (1994). Superior therapeutic activity of prolonged compared with bolus administration of 2′2′ difluorodeoxycytidine (gemcitabine) in vivo against murine colon tumours. In Biochemical Pharmacology of Gemcitabine (2′2′ difluorodeoxycytidine). Ruiz van Haperen VU (ed.), 9, pp. 189 206. University Press: Amsterdam.
13. XU YZ AND PLUNKETT W. (1990). Regulation of dCMP deaminase in intact CCRF-CEM cells. Proc. Am. Assoc. Cancer Res., 30, abstract 2402.