A randomised phase II trial of docetaxel vs docetaxel and irinotecan in patients with stage IIIb-IV non-small-cell lung cancer who failed first-line treatment

British Journal of Cancer

Volumn 92, Issue 1, 2005, Pages 15-20

  Wachters, F M ^a   Groen, H J M ^a   Biesma, B ^b   Schramel, F M N H ^c   Postmus, P E ^d   Stigt, J A ^e   Smit, E F ^d,f  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b JEROEN BOSCH HOSPITAL   (Netherlands)

^c ST ANTONIUS HOSPITAL   (Netherlands)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e ISALA HOSPITAL   (Netherlands)

^f MARTINI HOSPITAL   (Netherlands)

Author keywords

Carcinoma; Clinical trial; Docetaxel; Irinotecan; Non small cell lung; Phase II; Second line chemotherapy

Indexed keywords

DOCETAXEL; GRANULOCYTE COLONY STIMULATING FACTOR; IRINOTECAN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; GRANULOCYTOPENIA; HUMAN; INFECTION; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MYALGIA; NAUSEA; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SIDE EFFECT; SKIN MANIFESTATION; THROMBOCYTOPENIA; TREATMENT FAILURE; VOMITING;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; TAXOIDS;

EID: 13244283059     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6602268     Document Type: Article

References (26)

1. Adjei AA, Klein CE, Kastrissios H, Goldberg RM, Alberts SR, Pitot HC, Sloan JA, Reid JM, Hanson LJ, Atherton P, Rubin J, Erlichman C (2000) Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: preliminary evidence of clinical activity. J Clin Oncol 18: 1116-1123
2. Anderson H, Hopwood P, Stephens RJ, Thatcher N, Cottier B, Nicholson M, Milroy R, Maughan TS, Falk SJ, Bond MG, Burt PA, Connolly CK, McIllmurray MB, Carmichael J (2000) Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer: a randomized trial with quality of life as the primary outcome. Br J Cancer 83: 447-453
3. Argiris A (2003) Celecoxib combined with weekly irinotecan (CPT-11) and docetaxel for the treatment of patients with advanced non-small cell lung cancer (NSCLC). Lung Cancer 41(Suppl 2): S179
4. Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL (1999) Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol 17: 3188-3194
5. Fossella FV, Devore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L (2000) Randomized phase III trial of docetaxel vs vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 18: 2354-2362
6. Fossella FV, Lee JS, Shin DM, Calayag M, Huber M, Perez-Soler R, Murphy WK, Lippman S, Benner S, Glisson B (1995) Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer. J Clin Oncol 13: 645-651
7. Frasci G, Comella P, Thomas R, Di Bonito M, Lapenta L, Capasso I, Botti G, Vallone P, De RV, D'Aiuto G, Comella G (2004) Biweekly docetaxel - irinotecan with filgrastim support in pretreated breast and non-small-cell lung cancer patients. A phase I study. Cancer Chemother Pharmacol 53: 25-32
8. Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N (1992) A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer. J Clin Oncol 10: 16-20
9. Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JY, Nishiwaki Y, Vansteenkiste J, Kudoh S, Rischin D, Eek R, Horai T, Noda K, Takata I, Smit E, Averbuch S, Macleod A, Feyereislova A, Dong RP, Baselga J (2003) Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 21: 2237-2246
10. Gandara DR, Vokes E, Green M, Bonomi P, Devore R, Comis R, Carbone D, Karp D, Belani C (2000) Activity of docetaxel in platinum-treated non-small-cell lung cancer: results of a phase II multicenter trial. J Clin Oncol 18: 131-135
11. Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, Von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn Jr PA (2004) Randomized phase III trial of pemetrexed vs docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22: 1589-1597
12. Hoskins P, Eisenhauer E, Beare S, Roy M, Drouin P, Stuart G, Bryson P, Grimshaw R, Capstick V, Zee B (1998) Randomized phase II study of two schedules of topotecan in previously treated patients with ovarian cancer: a National Cancer Institute of Canada Clinical Trials Group study. J Clin Oncol 16: 2233-2237
13. Kehrer DF, Sparreboom A, Verweij J, de Bruijn P, Nierop CA, van de SJ, Ruijgrok EJ, de Jonge MJ (2001) Modulation of irinotecan-induced diarrhea by cotreatment with neomycin in cancer patients. Clin Cancer Res 7: 1136-1141
14. Mäenpää J, Käär K, Kivinen S, Pohto M, Jekunen A (1999) Docetaxel and CPT-11 for recurrent ovarian cancer. A Phase II Study. Proc Am Soc Clin Oncol 18: 363a
15. Masuda N, Negoro S, Kudoh S, Sugiura T, Nakagawa K, Saka H, Takada M, Niitani H, Fukuoka M (2000) Phase I and pharmacologic study of docetaxel and irinotecan in advanced non-small-cell lung cancer. J Clin Oncol 18: 2996-3003
16. Negoro S, Masuda N, Takada Y, Sugiura T, Kudoh S, Katakami N, Ariyoshi Y, Ohashi Y, Niitani H, Fukuoka M (2003) Randomised phase III trial of irinotecan combined with cisplatin for advanced non-small-cell lung cancer. Br J Cancer 88: 335-341
17. Non-small Cell Lung Cancer Collaborative Group (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. BMJ 311: 899-909
18. Ranson M, Davidson N, Nicolson M, Falk S, Carmichael J, Lopez P, Anderson H, Gustafson N, Jeynes A, Gallant G, Washington T, Thatcher N (2000) Randomized trial of paclitaxel plus supportive care vs supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 92: 1074-1080
19. Robinet G, Thomas P, Perol M, Vergnenegre A, Lena H, Taytard A, Paillotin D, Bessa EH, Schuller-Lebeau MP (2000) Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology. Rev Mal Respir 17: 83-89
20. Sanchez R, Esteban E, Palacio I, Fernandez Y, Muniz I, Vieitez JM, Fra J, Blay P, Villanueva N, Una E, Mareque B, Estrada E, Buesa JM, Lacave AJ (2003) Activity of weekly irinotecan (CPT-11) in patients with advanced non-small cell lung cancer pretreated with platinum and taxanes. Invest New Drugs 21: 459-463
21. Satouchi M, Takada Y, Takeda K, Yamamoto N, Negoro S, Nakagawa K, Matsui K, Kawahara M, Fukuoka M, Ariyoshi H (2001) Randomized phase II Study of docetaxel plus cisplatin vs docetaxel plus irinotecan in advanced non-small cell lung cancer (NSCLC); A West Japan Thoracic Oncology Group (WJTOG) Study. Proc Am Soc Clin Oncol 20: 329a
22. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346: 92-98
23. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J (2000) Prospective randomized trial of docetaxel vs best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18: 2095-2103
24. Simon R, Wittes RE, Ellenberg SS (1985) Randomized phase II clinical trials. Cancer Treat Rep 69: 1375-1381
25. Souquet PJ, Chauvin F, Boissel JP, Cellerino R, Cormier Y, Ganz PA, Kaasa S, Pater JL, Quoix E, Rapp E (1993) Polychemotherapy in advanced non small cell lung cancer: a meta-analysis. Lancet 342: 19-21
26. World Health Organisation (1979) WHO Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: WHO