Open, randomized, phase II study of single-agent gemcitabine and docetaxel as first- and second-line treatment in patients with advanced non-small-cell lung cancer

Clinical Lung Cancer

Volumn 8, Issue 4, 2007, Pages 245-251

  Manegold, Christian ^a   Koschel, Gabriele ^a   Hruska, Dagmar ^a   Schott von Römer, Kathrin ^a   Mezger, Jörg ^a   Pilz, Lothar Richard ^a  

^a GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

Author keywords

Chemotherapy; Clinical study

Indexed keywords

DOCETAXEL; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; FEBRILE NEUTROPENIA; FEMALE; GRANULOCYTOPENIA; HUMAN; INFECTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING;

EID: 33847408454     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2007.n.001     Document Type: Article

References (40)

1. ESMO minimum clinical recommendations for diagnosis, treatment and follow-up of non-small-cell lung cancer (NSCLC). Ann Oncol 2001; 12:1049-1050.
2. Pfister DG, Johnson DH, Azzoli CG, et al. American Society of Clinical oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004; 22:330-353.
3. Roszkowski K, Pluzanska A, Krzakowski M, et al. A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 2000; 27:145-157.
4. Manegold C, Bergman B, Chemaissani A, et al. Single-agent gemcitabine versus cisplatin-etoposide: early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer. Ann Oncol 1997; 8:525-529.
5. Crino L, Mosconi AM, Scagliotti G, et al. Gemcitabine as second-line treatment for advanced non-small-cell lung cancer: a phase II trial. J Clin Oncol 1999; 17:2081-2085.
6. Fosella FV. Docetaxel for previously treated non-small-cell lung cancer. Oncology 2002; 16(6 suppl):45-51.
7. Gridelli C, Ardizzoni A, Le Chevalier T, et al. Treatment of advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an European Experts Panel. Ann Oncol 2004; 15:419-426.
8. Manegold C, Pilz LR, Koschel G, et al. Randomized multicenter phase II study of gemcitabine versus docetaxel as first-line therapy with second-line crossover in advanced-stage non-small-cell lung cancer. Clin Lung Cancer 2005; 7:208-214.
9. Giaccone G, Natale RB, Schiller JH, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial - INTACT 1. J Clin Oncol 2004; 22:777-784.
10. Smit EF, van Meerbeeck JPAM, Lianes P, et al. Three-arm randomised study of two platinum-based regimens and paclitaxel plus Gemcitabine in advanced non-small cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer. Lung Cancer Group - EORTC 08975. J Clin Oncol 2003; 21:3909-3917.
11. Rudd RM, Gower NH, Spiro SG, et al. Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group. J Clin Oncol 2005; 23:142-153.
12. Kelly K, Crowley J, Bunn PA Jr, et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol 2001; 19:3210-3218.
13. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 2002; 346:92-98.
14. Fayers P, Bottomley A, on behalf of the EORTC Quality of Life Group and of the Quality of Life Unit. Quality of life research within the EORTC - the EORTC QLQ-C30. Eur J Cancer 2002; 38:S125-S133.
15. Bergman B, Aaronson NK, Ahmedzai S, et al. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer 1994; 30A:635-642.
16. WHO handbook for reporting results of cancer treatment, No. 48. Geneva, World Health Organization Offset Publication, 1979.
17. German Phase I, II and III Study Group of the Association for Medical Oncology of the German Cancer Society. Phase I and Phase II Study Groups. Onkologie 1998; 21(3 suppl):1-61.
18. Koziol JA, Maxwell DA, Fukushima M, et al. A distribution-free test for tumor-growth curve analyses with application to an animal tumor immunotherapy experiment. Biometrics 1981; 37:383-390.
19. Le Chevalier T, Brisgand D, Douillard J, et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced NSCLC: results of an European multicenter trial including 612 patients. J Clin Oncol 1994; 12:360-367.
20. Gatzemeier U, von Pawel J, Gottfried M, et al. Phase III comparative study of high dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced NSCLC. J Clin Oncol 2000; 18:3390-3399.
21. Georgoulias V, Ardavanis A, Agelidou A, et al. Docetaxel versus docetaxel plus cisplatin as front-line treatment of patients with advanced non-small-cell lung cancer: a randomized, multicenter phase III trial. J Clin Oncol 2004; 22:2602-2609.
22. Sederholm C, Hillerdal G, Lamberg K, et al. Phase III trial of gemcitabine plus carboplatin versus single-agent gemcitabine in the treatment of locally advanced or metastatic non-small-cell lung cancer: the Swedish Lung Cancer Study Group. J Clin Oncol 2005; 23:8380-8388.
23. Depierre A, Chastang C, Quoix E, et al. Vinorelbine versus vinorelbine plus cisplatin in advanced NSCLC: a randomized trial. Ann Oncol 1994; 5:37-42.
24. Perng RP, Chen YM, Ming-Liu J, et al. Gemcitabine versus the combination of cisplatin and etoposide in patients with inoperable NSCLC in a phase II randomized study. J Clin Oncol 1997; 15:2097-2102.
25. Vansteenkiste JF, Vandebroek JE, Nackaerts KL, et al. Clinical benefit response in advanced NSCLC: a multicentre prospective randomized phase III study of single agent gemcitabine versus cisplatin-vindesine. Ann Oncol 2001; 12:1221-1230.
26. Negoro S, Masuda N, Takada Y, et al. Randomized phase III trial of irinotecan combined with cisplatin for advanced NSCLC. Br J Cancer 2003; 88:335-341.
27. Wozniak AJ, Crowley JJ, Balcerzak SP, et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced NSCLC: a Southwest Oncology Group study. J Clin Oncol 1998; 16:2459-2465.
28. Sandler A, Nemunaitis J, Denham C, et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic NSCLC. J Clin Oncol 2000; 18:122-130.
29. The Elderly Lung Cancer Vinorelbine Italian Study Group. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 1999; 91:66-72.
30. Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 2003; 95:362-372.
31. Ferrigno D, Buccheri G; Cuneo Lung Cancer Study Group. Front-line weekly chemotherapy with Gemcitabine for unfit patients with non-small cell lung cancer (NSCLC). Lung Cancer 2004; 45:373-380.
32. Neubauer MA, Reynolds CH, Joppert MG, et al. Results of a phase II trial of Gemcitabine in patients with non-small-cell lung cancer and a performance status of 2. Clin Lung Cancer 2005; 6:245-249.
33. Monnier A, Zatloukal P, Siffnerova H, et al. Docetaxel (D) versus vinorelbine-cisplatin (VC) as front-line treatment for patients with advanced non-small cell lung cancer (NSCLC) and with a normal level of serum α1-acid glycoprotein (AAG): Additional data on quality of life (QoL): preliminary results. Proc Am Soc Clin Oncol 2003; 22:666 (Abstract #2680).
34. Rinaldi M, Crino L, Scagliotti GF, et al. A 3-week schedule of gemcitabine/cisplatin in advanced non-small cell lung cancer with two different cisplatin dose levels: A phase II randomised trial. Ann Oncol 2000; 11:1295-1300.
35. Soto Parra H, Cavina R, Latteri F, et al. Three-weeks versus four-weeks schedule of cisplatin and gemcitabine: results of randomised phase II study. Ann Oncol 2002; 13:1080-1086.
36. Cardenal F, Lopez-Cabrerizo MP, Anton A, et al. Randomised phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small cell lung cancer. J Clin Oncol 1999; 17:12-18.
37. Scagliotti GV, De Marinis F, Rinaldi M, et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 2002; 20:4285-4291.
38. Carrato A, Alberola V, Massuti B et al. Combination of gemcitabine and carboplatin as first-line treatment in non-small cell lung cancer. Ann Oncol 1998; 9:89-90 (Abstract# 431).
39. Carrato A, Garcia-Gomez J, Alberola V, et al. Carboplatin in combination with Gemcitabine in advanced non-small cell lung cancer: comparison of trials using different schedules. Proc Am Soc Clin Oncol 1999; 18:489a (Abstract #1922).
40. Manegold C, Thatcher N, Kortsik C, et al. A phase II/III randomized study in advanced non-small cell lung cancer (NSCLC) with first line combination versus sequential gemcitabine (G) and docetaxel (D): update on quality of life (QoL), toxicity, and costs. J Clin Oncol 2005; 23(16 suppl):634s (Abstract #7057).