Dose intensity phase l/li trial with carboplatin, ifosfamide, etoposide and vincristine combined with filgrastim in patients with small-cell lung cancer

Oncology (Switzerland)

Volumn 54, Issue 5, 1997, Pages 363-370

  Hanauske, Axel R ^a   Korfel, Agnieszka ^d   Perker, Michael ^a   Heinrich, Bernhard ^a   Schwab, Gisela ^b   Graf, Martina ^b   Depenbrock, Henrik ^a   Gert, Höffken ^d   Kreuser, Ernst D ^d   Thiel, Eckhard ^d   Zwingers, Thomas ^c   Berdel, Wolfgang E ^d  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b AMGEN INC   (United States)

^c Estimate   (Germany)

^d CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Chemotherapy; Dose intensity; Filgrastim; Phase I II; r MetHuG CSF; Small cell lung cancer

Indexed keywords

CARBOPLATIN; ETOPOSIDE; IFOSFAMIDE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; VINCRISTINE;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG SAFETY; FEASIBILITY STUDY; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; HEART INFARCTION; HEMIPLEGIA; HUMAN; HUMAN CELL; INFECTION; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY FAILURE; LUNG SMALL CELL CANCER; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; RESPIRATORY TRACT DISEASE; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS, ALKYLATING; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, SMALL CELL; DRUG ADMINISTRATION SCHEDULE; ETOPOSIDE; FEASIBILITY STUDIES; FEMALE; FILGRASTIM; HEMATOPOIESIS; HUMANS; IFOSFAMIDE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEUTROPENIA; THROMBOCYTOPENIA; TREATMENT OUTCOME; VINCRISTINE;

EID: 0030812210     PISSN: 00302414     EISSN: 14230232     Source Type: Journal    
DOI: 10.1159/000227719     Document Type: Article

References (43)

1. Hansen HH, Kristjansen PE: Chemotherapy of small-cell lung cancer. Eur J Cancer 1991:27: 342-349.
2. Smith IE, Harland SJ, Robinson BA, Evans BD, Goodhart LC, Calvert AH, Yamold J, Glees JP, Baker J, Ford HT: Carboplatin: A very active new cisplatin analog in the treatment of small-cell lung cancer. Cancer Treat Rep 1998:5:69:43-46.
3. Jacobs RH, Bitran JD, Deutsch M, Hoffmann PC, Sinkulc J, Purl S, Golomb HM: Phase II study of carboplatin in previously untreated patients with metastatic small cell lung carcinoma. CancerTreat Rep 1987:71:311-312.
4. Drings P: Ifosfamidc in the treatment of bronchial carcinoma; in Nagel GA. Seeber S. Bradc WP (eds): Ifosfamidc in Tumor Therapy. Con-trib Oncol. Basel, Karger, 1987, pp 294-318.
5. Warenius HM, Hurman DC, Cottier B: High dose ifosfamidc in small cell cancer. Br J Cancer 1986;54:216.
6. Fleming RA, Miller AA, Stewart CF: Etopo-side: An update. Clin Pharm 1989:8:274-293.
7. Gatzemcier U, Hossfeld DK, Neuhaus R, Reck M, Achterrath W, Lenaz L: Carboplatin in small-cell lung cancer. Semin Oncol 1995:18: 8-16.
8. Gatzemcier U, Neuhaus R, Pawel JV, Karn-mann R, Laumen R, Hossfeld DK: Carbopla-tin/etoposide/vincristine (CEV) versus etopo-sidc/vincristinc (VCR) (EV) in extensive stage small cell lung cancer - A randomized phase 111 trial. Proc Am Soc Clin Oncol 1991; 10:244.
9. Smith IE, Perren TJ, Ashley SA, Woodiwiss J, Forgeson GV, Yamold JR, Ford HT: Carboplatin. etoposidc and ifosfamide as intensive chemotherapy for small-cell lung cancer. J Clin Oncol 1990;8:899-905.
10. Thatcher N, Lind M, Stout R, Payne C, Caroll KB, Campbell C, Moussolli H: Carboplatin, ifosfamide and etoposidc with mid-course vincristine and thoracic radiotherapy for 'limited' stage small cell carcinoma of the bronchus. Br J Cancer 1989:60:98-101.
11. Johnson DM, Greco FA: Small-cell lung cancer: Current perspectives. Am J Med Sci 1987:293: 377-398.
12. Thatcher N: Ifosfamide/carboplatin/etoposide (ICE) regimen in small cell lung cancer. Lung Cancer 1993;9:S51-S67.
13. Johnson DH, Einhom LH, Birch R, Vollmer R, Perez C, Krauss S, Ontura G, Greco FA: A randomized comparison of high dose versus conventional dose cyclophosphamide, doxorubicin and vineristine for extensive stage small cell lung cancer: A phase 111 trial of the Southeastern Cancer Study Group. J Clin Oncol 1987;5: 1731-1738.
14. Cohen MH, Creaven PJ, Fossick BE: Intensive chemotherapy of small-cell bronchogenic carcinoma. Cancer Treat Rep 1977:61:349-354.
15. Arriagada R, Le Chevalier T, Pignon J-P, Rivière A, Monnet I, Chorny P, Tuchais C, Ta-rayre M, Ruffic P: Initial chemotherapeutic doses and survival in patients with limited small-cell lung cancer. N Engl J Med 1993:329: 1848-1852.
16. Taylor CW, Crowley J, Williamson SK, Miller TP, Taylor SA, Shanker Giri TG, Stephens RL, Livingston RB: Treatment of small-cell lung cancer with an alternating chemotherapy regimen given at weekly intervals: A Southwest Oncology Group Pilot study. J Clin Oncol 1990;8:1811-1817.
17. Miles DW, Souhami RL, Spiro SG, Rudd RM, Ash CM, Trask CWL, James L, Harper PG: A randomized trial comparing 'standard' 3 weekly with weekly chemotherapy (C/T) in patients (PTS) with small cell lung cancer (SCLC). Proc Am Soc Clin Oncol 1992; 11:289.
18. Murray N, Shah A, Osoba D, Page R, Karsai H, Grafton C, Goddard K, Fairey R, Voss N: Intensive weekly chemotherapy for the treatment of cxtensive-stage small-cell lung cancer. J Clin Oncol 1991:9:1632-1638.
19. Ardizzoni A, Venturini M, Crino L, Sertoli M, Bruzzi P, Pennucci MC, Mariani GL, Garrone O, Bracarda S, Rosso R, van Zandwijk N: High dose-intensity chemotherapy, with accelerated cyclophosphamide-doxorubicin-etoposide and granulocyte-macrophage colony stimulating factor, in the treatment of small cell lung cancer. Eur J Cancer 1993;29A:687-692.
20. Trillet-Lenoir V, Green J, Manegold C, von Pawel J, Gatzcmeier U, Lebeau B, Depierre A, Johnson P, Decoster G, Tornita D, Ewen C: Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer 1993; 29A:319-324.
21. Crawford J, Ozer H, Stoller R, Johnson D, Lyman G, Tabbara I, Kris M, Grous J, Picozzi V, Rausch G, Smith R, Gradishar W, Yahanda A, Vincent M, Stewart M, Giaspv J: Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 1991:315:164-170.
22. Bronchud MH, Scarffc JH, Thatcher N, Crowther D, Souza IM, Alton NK, Testa NG, Dexter TM: Phase I/ll study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small lung cancer. Br J Cancer 1987:56: 809-813.
23. Fukuoka M, Masuda N, Takada M, Kodama N, Kawahara M, Furuse K: Dose intensive chemotherapy in extensive-stage small cell lung cancer. Semin Oncol 1994:21:43-47.
24. Prendiville J, Lorigan P, Hicks F, Leahy B, Stout R, Burt P, Thatcher N: Therapy for small cell lung cancer using carboplatin, ifosfamide. etoposidc (without dose reduction), mid-cycle vincristine with thoracic and cranial irradiation. Eur J Cancer 1994:30A:2085-2090.
25. Thatcher N, Lorrigan P, Burt P, Stout R: Intensive combined-modality therapy in small cell lung cancer. Semin Oncol 1994:21:9-22.
26. Seifter EJ, Ihde DC: Therapy of small cell lung cancer: A perspective on two decades of clinical research. Semin Oncol 1988:15:278-299.
27. Skarlos DV, Samantas E, Kosmidis P, Fountzi-las G, Angelidou M, Palamidas P, Mylonakis N, Provata A, Papadakis E, Klouvas G, Theo-charis D, Panousaki E, Boleti E, Sphakianoudis G, Pavlidis N: Randomized comparison of cto-poside-cisplatin vs. etoposide-carboplatin and irradiation in small-cell lung cancer: A Hellenic Co-Operative Oncology Group study. Ann Oncol 1994:5:601-607.
28. Lochrer PJS, Rynard S, Ansari R, Songer J, Pennington K, Einhorn L: Etoposide. ifosfamide, and cisplatin in extensive small-cell lung cancer. Cancer 1992;69:669-673.
29. Gatzemcier U, Hossfeld DK, Neuhauss R, Reck M, Achterrath W, Lenaz L: Combination chemotherapy with carboplatin. etoposide. and vincristine as first-line treatment in small-cell lung cancer. J Clin Oncol 1992; 10:818.
30. Johnson DH: Recent developments in chemotherapy treatment of small-cell lung cancer. Semin Oncol 1993:20:315-325.
31. Backstein ME: Advances in chemotherapy for small cell lung cancer. Semin Oncol 1994:21: 38-42.
32. Gurney H, Dodwell D, Thatcher N, Tattersall MHN: Escalating drug delivery in cancer chemotherapy: A review of concepts and practice. Part I. Ann Oncol 1993;4:23-34.
33. Klasa RJ, Murray N, Coldman AJ: Dose-inten-sity meta-analysis of chemotherapy regimens in small-cell carcinoma of the lung. J Clin Oncol 1991;9:499-508.
34. Ardizzoni A, Venturini M, Sertoli MR, Pennucci MC, Mariani GL, Lionetto R, Crino L, Bracarda S, Tonato M, Addanto GF, Rosso R, van Zandwijk N: Accelerated chemotherapy with GM-CSF in small cell lung cancer (SCLC) patients: A Phase II study. Ann Oncol 1992; 3:1.
35. Eguchi K, Etou S, Miyachi S, Morinari H, Nakada K, Noda K, Ohkuni Y, Watanabe K. Yamada Y, Ohe Y, Tamura T, Sasaki Y, Shin-kai T, Saijo N: A study of dose escalation of teniposide (VM 26) plus cisplatin (CDDP) with recombinant human granulocyte colony-stimulating factor (rhG-CSF) in patients with advanced small cell lung cancer. Eur J Cancer 1954;30A: 188-194.
36. Sertoli MR, Qucirolo P, Miglio LP, Mariani GL, Venturini M, Ardizzoni A, Viscoli C, Rosso R: Phase I accelerated CMF with G-CSF support in metastatic breast cancer. Proc Am Soc Clin Oncol 1993:12:96.
37. Loehrer PJ, Elson P, Dreiccr R, Hahn R, Nichols CR, Williams R, Einhorn LH: Escalated dosages of methotrexate, vinblastine, doxorubicin. and cisplatin plus recombinant human granulocyte colony-stimulating factor in advanced urothelial carcinoma: An Eastern Cooperative Oncology Group Trial. Clin Oncol 1994;12:483-488.
38. Seidman AD, Scher HI, Gabrilove JL, Bajorin DF, Motzer RJ, O'Dell M, Curley T, Dershaq DD, Quinlivan S, Tao Y, Fair WR, Begg C, Bosl GJ: Dose-intensification of MVAC with recombinant granulocyte colony-stimulating factor as initial therapy in advanced urothelial cancer. J Clin Oncol 1993; 11:408-411.
39. Saijo N, Eguchi K, Etou H, Miyachi S, Mori-nari H, Nakada K, Noda K, Ohkuni Y, Wata-nabe K, Yamada Y, Kabe J, Kudo S, Mano K, Tanaka T, Uzawa T, Ohe Y, Tamura T, Sasaki Y, Shinkai T: The role of granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor in chemotherapy for lung cancer. Semin Oncol 1994;21:54-58.
40. Mori K, Saitoh Y, Tominaga K: Recombinant human granulocyte colony stimulating factor in patients receiving intensive chemotherapy for non-small cell lung cancer. Eur J Cancer 1993:5:677-680.
41. Dodwell DJ, Gurney H, Thatcher N: Dose intensity in cancer chemotherapy. Br J Cancer 1990;61:789-794.
42. Miles DW, Earl HM, Souhami RL, Harper PG, Rudd R, Ash CM, James L, Trask CWL, Tobias JS. Spiro SG: Intensive weekly chemotherapy for good-prognosis patients with small-cell lung cancer. J Clin Oncol 1991;9:280-285.
43. Woll PJ, Hodgetls J, Lomax L, Bildet F, Cour Chabernaud V, Thatcher N: Can cytotoxic dose-intcnsity be increased by using granulocyte colony-stimulating factor? A randomized controlled trial of lenograstim in small-cell lung cancer. J Clin Oncol 1995; 13:652-659.