Phase I/II trial of gemcitabine plus docetaxel in advanced non small cell lung cancer (NSCLC)

Investigational New Drugs

Volumn 22, Issue 3, 2004, Pages 291-297

  Israel, Valerie ^a,b   Tagawa, Scott T ^a   Snyder, Terry ^a   Jeffers, Susan ^a   Raghavan, Derek ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b California Cancer Medical Center   (United States)

Author keywords

Chemotherapy; Docetaxel; Gemcitabine; Lung cancer

Indexed keywords

ANTIINFECTIVE AGENT; DEXAMETHASONE; DOCETAXEL; GEMCITABINE; TAXANE DERIVATIVE;

ADULT; AGED; ALLERGIC REACTION; ALLERGY; ANEMIA; ARTICLE; BRAIN METASTASIS; CAPILLARY LEAK SYNDROME; CLINICAL ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; DISEASE COURSE; DISEASE EXACERBATION; DRUG CYTOTOXICITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FOLLOW UP; HUMAN; LIVER FUNCTION; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; NAUSEA; NEUROLOGICAL COMPLICATION; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; SIDE EFFECT; SYSTEMIC THERAPY;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; COHORT STUDIES; DEOXYCYTIDINE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; TAXOIDS; TREATMENT OUTCOME;

EID: 3543004697     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:DRUG.0000026255.34988.96     Document Type: Article

References (35)

1. American Cancer Society Cancer Facts and Figures, 2003
2. Minna JD, Pass H, Glatstein E, Ihde DC: Cancer of the lung. In DeVita VT, Hellman S, Rosenberg SA (eds), Cancer: Principles & Practice: of Oncology, 3rd edition, JB. Lippincott Co., Philadelphia, 1989
3. Gralla RJ, Kris MG: Chemotherapy in non-small cell lung cancer: Results of recent trials. Semin Oncol 15(suppl 4): 2-5, 1988
4. Casper ES, Gralla RJ, Kelson DP, Citovic E, Golbey RB: Phase II study of high dose cis-diachlorodiammine-platinum (II) in the treatment of non-small cell lung cancer. Cancer Treat Rep 63: 2107-2109, 1979
5. De Jager R, Longeval I, Klatersky J: High dose cisplatin with fluid and mannitol induced diuresis in advanced lung cancer: A phase II clinical trial of EORTC lung cancer working party (Belgium). Cancer Treat Rep 64: 1341-1346, 1980
6. Furnas BE, Williams SD, Einhorn LH, Cobleigh MA: Vindesine, an effective agent in the treatment of non-small cell lung cancer. Cancer Treat Rep 66: 1709-1711, 1982
7. Luedke SL, Luedke DW, Petruska P, Broun GO, Reed G, Leavitt J: Vindesine (VDS) monochemotherapy for non small cell lung cancer: A report of 45 cases. Cancer Treat Rep 66: 1409-1411, 1982
8. Gralla RJ, Raphael BG, Golbey RB, Young CW: Phase II evaluation of vindesine in patients with non-small cell carcinoma of the lung. Cancer Treat Rep 63: 1343-1346, 1979
9. Gralla RJ, Casper ES, Kelsen DP, Braun DW, Dukeman ME et al: Cisplatin and vindesine in combination chemotherapy for advanced carcinoma of the lung: A randomized trial investigating two dosage schedules. Ann Intern Med 95: 414-420, 1981
10. Woodcock TM, Blumenreich MS, Richman SP, Kubota TT, Gentile PS, Allegra JC: Combination chemotherapy with cis-diammine-dichloroplatinum and vinblastine in advanced non small cell lung cancer. J Clin Oncol 1: 247-250, 1983
11. Spain RC: Neoadjuvant mitomycin C, cisplatin, and infusion vinblastine in locally and regionally advanced non-small cell lung cancer: Problems and progress from the perspective of long term follow-up. Semin Oncol 15(Suppl 4): 6-15, 1988
12. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. NEJM 346: 92-98, 2002
13. Dorr RT, Von Hoff DD: Cancer chemotherapy Handbook, 2nd edition. Appleton & Lange, Norwalk CT, 1994, pp. 259-267
14. Bruno R, Sanderink GJ: Pharmacokinetics and metabolism of docetaxel (Taxotere). Cancer Surveys: Pharmacokinet Cancer Chemother 17: 305-313, 1993
15. Ringel I, Horwitz SB: Studies with RP 56976 (Taxotere): A semisynthetic analogue of taxol. J Natl Cancer Inst 83: 288-291, 1991
16. Bissery MC, Guénard D, Guéritte-Voegelein F, Lavelle F: Experimental antitumor activity of taxotere (RP 56976, NCS 628503), a taxol analogue. Cancer Res 51: 4845-4852, 1991
17. Verweij J, Clavel M, Chevalier B: Pachtaxel (Taxol®) and docetaxel (Taxotere®): Not simply two of a kind. Annals of Oncology 5: 495-505, 1994
18. Extra JM, Rousseau F, Bruno R et al: Phase I and pharmacokinetic study of Taxotere (RP 56976, NSC 628503) given as short I.V. infusion, every 21 days. Cancer Res 53: 1037-102, 1993
19. Riou JF, Petitgenet O, Combeau C et al: Cellular uptake and efflux of docetaxel (Taxotere) and paclitaxel (Taxol) in P388 cell line. Pro Am Assoc Can Res 35: 385, 1994
20. Francis PA, Rigas JR, Kris MG, Pisters MG, Orazem JP, Woolley KJ, Heelan RT: Phase II trial of docetaxel in patients with stage III and IV non-small cell lung cancer. J Clin Oncol 12: 1232-1237, 1994
21. Fossella FV, Lee JS, Murphy WK, Lippman SM, Calayag M, Pang A, Chasen M, Shin DM, Glisson B, Benner S: Phase II study of docetaxel for recurrent or metastatic non-small cell lung cancer. J Clin Oncol 12: 1238-1244, 1994
22. Burris H, Eckhardt J, Fields S, Rodriguez G, Smith L, Thurman A, Peacock N, Juhn J, Hodges S, Bellet R, Bayssas M, LeBail N, Von Hoff D: Phase II trial of taxotere in patients with non-small cell lung cancer. Proc Am Soc Clin Oncol 12: 335, 1993
23. Le Chevalier T: Single agent activity of Gemcitabine in advanced non-small cell lung cancer. Sem Oncol 1996; 23(Suppl 10): 36-42
24. Kaplan E, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457-481, 1958
25. Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. J Clin Oncol 15: 2996-3018, 1997
26. Socinski MA, Morris DE, Masters GA, Lilenbaum R: Chemotherapeutic management of stage IV non-small cell lung cancer. Chest 123: 226S-243S, 2003
27. Georgoulias V, Kouroussis C, Androulakis N, Kakolyris S, Dimopoulos M-A, Papadakis E, Bouros D, Apostolopoulou F, Papadimitriou C, Agelidou A, Hatzakis K, Kalbakis K, Kotsakis A, Vardakis N, Vlachonicolis J: Front-line treatment of advanced non-small-cell lung cancer with docetaxel and gemcitabine: A multicenter phase II trial. J Clin Oncol 17(3): 914-920, 1999
28. Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Veslemes M, Palamidas Ph, Vlachonikolis I: Platinum-based and non-platinum based chemotherapy in advanced non-small cell lung cancer: A randomized multicentre trial. Lancet 357: 1478-1484, 2001
29. Kosmidis P, Mylonakis N, Nicolaides C, Kalophonos C, Samantas E, Boukovinas J, Fountzilas G, Skarlos D, Econompoulos T, Tsavdaridis D, Papakostas P, Bacoyianis C, Dimopoulos M: Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: A phase III randomized trial. J Clin Oncol 17: 3578-3585, 2002
30. Lorusso V, Carpagnano F, Frasci G, Panza N, Di Rienzo G, Cisternino ML, Napoli G, Orlando S, Cinieri S, Brunetti C, Palazzo S, De Lena M: Phase I/II study of gemcitabine plus vinorelbine as first-line chemotherapy of non-small-cell lung cancer. J Clin Oncol 18: 405-411, 2000
31. Lilenbaum R, Cano R, Schwartz M, Siegel L, Lutzky J, Lewis M, Krill E, Barreras L, Davila E: Gemcitabine and vinorelbine in advanced Nonsmall cell lung carcinoma. Cancer 88: 557-562, 2000
32. Bajetta E, Chiaria Stani S, De Candis D, Bidoli P, Mariani L, Zilembo N, Pozzi P, Procopio G: Gemcitabine plus vinorelbine as first-line chemotherapy in advanced nonsmall cell lung carcinoma: A phase II trial. Cancer 89: 763-768, 2000
33. Gridelli C, Frontini L, Peronne F, Gallo C, Gulisano M, Cigolari S, Castiblione F, Robbiat SF, Gasparini G, Ianniello GP, Farris A, Locatelli MC, Felletti R, Piazza E: Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: A phase II study of three different doses. Br J Cancer 83: 707-714, 2000
34. Beretta GD, Michetti D, Belometti MO et al: Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer. Br J Cancer 83: 573-576, 2000
35. Frasci G, Lorusso V, Panza N, Comella P, Nicolella G, Bianco A, De Cataldis G, Iannelli A, Bilancia D, Belli M, Massidda B, Piantedosi F, Comella G, De Lena M: Gemcitabine plus vinorelbine versus vinorelbine alone in elderly patients with advanced non-small-cell lung cancer. J Clin Oncol 18: 2529-2536, 2000