Phase I study of gemcitabine given weekly as a short infusion for non-small cell lung cancer: Results and possible immune system-related mechanisms

Lung Cancer

Volumn 43, Issue 3, 2004, Pages 335-344

  Levitt, M L ^a,b   Kassem, B ^c   Gooding, W E ^c   Miketic, L M ^c   Landreneau, R J ^c   Ferson, P F ^c   Keenan, R ^c   Yousem, S A ^c   Lindberg, C A ^c   Trenn, M R ^c   Ponas, R S ^c   Tarasoff, P ^d   Sabatine, J M ^e   Friberg, D ^c   Whiteside, T L ^c  

^a TEL AVIV UNIVERSITY   (Israel)

^b UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^d ELI LILLY AND COMPANY   (United States)

^e ALLEGHENY GENERAL HOSPITAL   (United States)

Author keywords

Gemcitabine; Immune system related mechanisms; Non small cell lung cancer; Phase I; Short infusion

Indexed keywords

ALKALINE PHOSPHATASE; AMINOTRANSFERASE; CD16 ANTIGEN; CD19 ANTIGEN; CD3 ANTIGEN; CD4 ANTIGEN; CD56 ANTIGEN; CD8 ANTIGEN; FORMYLMETHIONYLLEUCYLPHENYLALANINE; GEMCITABINE; INTERLEUKIN 2; PHORBOL 13 ACETATE 12 MYRISTATE; SUPEROXIDE; TUMOR NECROSIS FACTOR; ZYMOSAN;

ADULT; AGED; ALLERGY; ALOPECIA; ANEMIA; ARTICLE; BIOLOGICAL MONITORING; BLEEDING; BLOOD TOXICITY; BRAIN CORTEX; BRAIN DISEASE; CANCER CHEMOTHERAPY; CANCER DIAGNOSIS; CANCER SURVIVAL; CARDIOTOXICITY; CHI SQUARE DISTRIBUTION; CLINICAL ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOKINE PRODUCTION; CYTOKINE RELEASE; DIARRHEA; DISEASE SEVERITY; DRUG INFUSION; DRUG TOLERABILITY; FEMALE; FEVER; FLU LIKE SYNDROME; GASTROINTESTINAL TOXICITY; HEART ARRHYTHMIA; HEART DISEASE; HEMATURIA; HUMAN; HUMAN CELL; HUMAN TISSUE; IMMUNE RESPONSE; IMMUNE SYSTEM; INFECTION; LEUKOCYTE COUNT; LEUKOPENIA; LIVER TOXICITY; LUNG DISEASE; LUNG NON SMALL CELL CANCER; LUNG TOXICITY; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; PAIN; PERICARDITIS; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; SIDE EFFECT; SKIN DISEASE; STATISTICAL SIGNIFICANCE; STOMATITIS; THROMBOCYTOPENIA; TOXICITY; TREATMENT OUTCOME; UROGENITAL TRACT DISEASE; VOMITING;

EID: 10744232091     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2003.09.011     Document Type: Article

References (19)

1. Minna JD, Pass J, Glatstein E, Ihde DC. Cancer of the lung. In: De Vita VTJ, Hellman S, Rosenberg SA, editors. Cancer: Principles and Practice of Oncology, 3rd ed. Philadelphia: J.B Lipppincott Co.; 1989. p. 591-705.
2. Ihde D.C., Minna J.D. Non-small cell lung cancer. Part I. Biology, diagnosis, and staging. Curr. Probl. Cancer. 15:1991;61-104.
3. Lilenbaum R.C., Green M.R. Novel chemotherapeutic agents in the treatment of non-small cell lung cancer. J. Clin. Oncol. 11:1993;1391-1402.
4. Ruiz van Haperen V.W., Veerman G., Vermorken J.B., Peters G.J. 2′,2′-Difluoro-deoxycytidine (gemcitabine) incorporation into RNA and DNA of tumour cell lines. Biochem. Pharmacol. 46:1993;762-766.
5. Heinemann V., Hertel L.W., Grindey G.B., Plunkett W. Comparison of the cellular pharmacokinetics and toxicity of 2′,2′- difluorodeoxycytidine and 1-beta-D-arabinofuranosylcytosine. Cancer Res. 48:1988;4024-4031.
6. Hertel L.W., Boder G.B., Kroin J.S., Rinzel S.M., Poore G.A., Todd G.C. et al. Evaluation of the antitumor activity of gemcitabine (2′,2′- difluoro-2′-deoxycytidine. Cancer Res. 50:1990;4417-4422.
7. Braakhuis B.J., van Dongen G.A., Vermorken J.B., Snow G.B. Preclinical in vivo activity of 2′,2′-difluorodeoxycytidine (gemcitabine) against human head and neck cancer. Cancer Res. 51:1991;211-214.
8. Poplin E.A., Corbett T., Flaherty L., Tarasoff P., Redman B.G., Valdivieso M.et al. Difluorodeoxycytidine (dFdC) - gemcitabine: a phase I study. Invest. New Drugs. 10:1992;165-170.
9. O'Rourke T.J., Brown T.D., Havlin K., Kuhn J.G., Craig J.B., Burris H.A.et al. Phase I clinical trial of gemcitabine given as an intravenous bolus on 5 consecutive days. Eur. J. Cancer. 30A:1994;417-418.
10. Abbruzzese J.L., Grunewald R., Weeks E.A., Gravel D., Adams T., Nowak B.et al. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J. Clin. Oncol. 9:1991;491-498.
11. Abbruzzese J.L. Phase I studies with the novel nucleoside analog gemcitabine. Semin. Oncol. 23(5 Suppl 10):1996;25-31.
12. Pollera C.F., Ceribelli A., Crecco M., Calabresi F. Weekly gemcitabine in advanced or metastatic solid tumors: a clinical phase I study. Invest. New Drugs. 12:1994;111-119.
13. Abratt R.P., Bezwoda W.R., Falkson G., Goedhals L., Hacking D., Rugg T.A. Efficacy and safety profile of gemcitabine in non-small-cell lung cancer: a phase II study. J. Clin. Oncol. 12:1994;1535-1540.
14. Anderson H., Lund B., Bach F., Thatcher N., Walling J., Hansen H.H. Single-agent activity of weekly gemcitabine in advanced non-small-cell lung cancer: a phase II study. J. Clin. Oncol. 12:1994;1821-1836.
15. Richards F., White D., Muss H., Powell B., Cruz J., Andes A.et al. Phase I trial of gemcitabine (2′,2′-difluorodeoxycytidine) over 30 min in patients with non small cell lung cancer. Proc. Am. Soc. Clin. Oncol. 13:1994;334. [abstract 1147].
16. Fossella F.V., Lippman S.M., Shin D.M., Tarassoff P., Calayag-Jung M., Perez-Soler R.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. 15:1997;310-316.
17. Friberg D., Bryant J., Shannon W., Whiteside T.L. In vitro cytokine production by normal human peripheral blood mononuclear cells as a measure of immunocompetence or the state of activation. Clin. Diagn. Lab. Immunol. 1:1994;261-268.
18. Newburger P.E., Chovaniec M.E., Cohen H.J. Activity and activation of the granulocyte superoxide-generating system. Blood. 55:1980;85-92.
19. Nowak A.K., Robinson B.W.S., Lake R.A. Gemcitabine exerts a selective effect on the humoral immune response: implications for combination chemo-immunotherapy. Cancer Res. 62:2002;2353-2358.