Phase I study of vinorelbine and ifosfamide in advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 15, Issue 3, 1997, Pages 884-892

  Masters, G A ^a   Hoffman, P C ^a   Hsieh, A ^a   Drinkard, L C ^a   Mick, R ^a   Samuels, B L ^a   Guaspari, A ^a   Golomb, H M ^a   Vokes, E E ^a  

^a University of Chicago   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; IFOSFAMIDE; MESNA; NAVELBINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE MARROW SUPPRESSION; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DOSE RESPONSE; DRUG CLEARANCE; FEMALE; FEVER; HUMAN; IMMUNE DEFICIENCY; INTRAVENOUS DRUG ADMINISTRATION; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MUCOSA INFLAMMATION; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SEPSIS; SUBCUTANEOUS DRUG ADMINISTRATION;

EID: 0031049131     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1997.15.3.884     Document Type: Article

References (50)

1. Boring C, Squires TN, Tong T, et al: Cancer statistics. CA 44:7-27, 1994
2. Vokes EE, Bitran JD: Non-small cell lung cancer: Towards the next plateau. Chest 106:659-661, 1994
3. Masters GA, Vokes EE: Am J Res Crit Care Med 151:1285-1287, 1995
4. Grilli R, Oxman AD, Julian JM: Chemotherapy is for advanced non-small cell lung cancer: How much benefit is enough? J Clin Oncol 11:1866-1872, 1993
5. Souquet PJ, Chauvin F, Boissel JP, et al: Polychemotherapy in advanced non-small cell lung cancer: A meta-analysis. Lancet 342:19-21, 1993
6. Marino P, Pampallona S, Preatoni A, et al: Chemotherapy versus supportive care in advanced non-small cell lung cancer: Results of a meta-analysis of the literature. Chest 106:861-865, 1994
7. Non-Small Cell Lung Cancer Collaborators Group: Chemotherapy in non-small cell lung cancer: A meta-analysis using updated data on individual patient from 52 randomized clinical trials. Br Med J 311:899-909, 1995
8. Cormier Y, Bergeron D, La Forge J, et al: Benefits of polychemotherapy in advanced non-small cell bronchogenic carcinoma. Cancer 50:845-849, 1982
9. Rapp E, Pater JL, Willan A, et al: Chemotherapy can prolong survival in patients with advanced non-small-cell lung cancer -Report of a Canadian multicenter randomized trial. J Clin Oncol 6:633-641, 1988
10. Woods RL, Williams CJ, Levi J, et al: A randomized trial of cisplatin and vindesine versus supportive care only in advanced non-small cell lung cancer. Br J Cancer 61:608-611, 1990
11. Quoix E, Dietermann A. Charbonneau J, et al: La chimiotherapie comportant du cisplatine est-elle utile dans le cancer bronchique non microcellulaire au stade IV? Resultants d'une etude randomisee. Bull Cancer 78:341-346, 1991
12. Cellerino R, Tummarello D, Guidi F, et al: A randomized trial of alternating chemotherapy versus best supportive care in advanced non-small cell lung cancer. J Clin Oncol 9:1453-1461, 1991
13. Kaasa S, Lund E, Thorud E, et al: Symptomatic treatment versus combination chemotherapy for patients with extensive non-small cell lung cancer. Cancer 67:2443-2447, 1991
14. Le Chevalier T, Arriagada R, Quoix E, et al: Radiotherapy alone versus combined chemotherapy and radiotherapy in nonresectable non-small-cell lung cancer. J Natl Cancer Inst 83:417-423, 1991
15. Dillman RO, Seagren SL, Propert KJ, et al: A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small cell lung cancer. N Engl J Med 323:940-945, 1990
16. Sause W, Scott C, Taylor S, et al: RTOG 8808/ECOG 4588, preliminary analysis of a phase III trial in regionally advanced unresectable non-small cell lung cancer. Proc Am Soc Clin Oncol 13:325, 1994 (abstr 1072)
17. Vokes EE, Bitran JD, Vogelzang NJ: Chemotherapy for non-small cell lung cancer: The continuing challenge. Chest 99:1326-1328, 1991 (editorial)
18. Haraf DJ, Devine S, Vokes EE: The evolving role of systemic therapy in carcinoma of the lung. Semin Oncol 19:72-87, 1994(suppl 11)
19. Sculier JP, Klastersky J, Giner V, et al: Phase II randomized trial comparing high-dose cisplatin with moderate-dose cisplatin and carboplatin in patients with advanced non-small cell lung cancer. J Clin Oncol 12:353-359, 1994
20. Lilenbaum RC, Green MR: Novel chemotherapeutic agents in the treatment of non-small-cell lung cancer. J Clin Oncol 11:1391-1402, 1993
21. Le Chevalier T, Brisgand D, Douillard JY, et al: Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: Results of a European multicenter trial including 612 patients. J Clin Oncol 12:360-367, 1994
22. Belli L, LeChevalier T, Gottfried M, et al: Phase I-II trial of paclitaxel (Taxol) and cisplatin in previously untreated advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 14:350, 1995 (abstr 1058)
23. LeChevalier T, Belli L, Monnier A, et al: Phase II study of docetaxel (Taxotere) and cisplatin in advanced non-small cell lung cancer: An interim analysis. Proc Am Soc Clin Oncol 14:350, 1995 (abstr 1059)
24. Sandler AB, Ansari R, McClean J, et al: A Hoosier Oncology Group phase II study of gemcitabine plus cisplatin in non-small cell lung cancer. Proc Am Soc Clin Oncol 14:357, 1995 (abstr 1089)
25. Vokes EE: Integration of vinorelbine into chemotherapy strategies for non-small cell lung cancer. Oncology 9:565-577, 1995
26. Binet S, Chineau E, Fellous A, et al: Immunofluorescence study of the action of Navelbine, vincristine, and vinblastine on mitotic and axonal microtubules. Int J Cancer 46:262-266, 1990
27. Fellous A, Ohayon R, Vacassin T, et al: Biochemical effects of Navelbine on tubulin and associated proteins. Semin Oncol 16:9-14, 1989
28. Mathe G, Reizenstein P: Phase I pharmacologic study of a new vinca alkaloid: Navelbine. Cancer Lett 27:285-293, 1985
29. Favre R, Garnier G, Depierre A, et al: A phase I study of Navelbine (nor-5′-anhydrovinblastine). Recent Adv Chemother 641-642, 1985
30. Vokes EE, Rosenberg RK, Jahanzeb M, et al: Multicenter phase II study of weekly oral vinorelbine for stage IV non-small-cell lung cancer J Clin Oncol 13:637-644, 1995
31. Depierre A, Lemarie E, Dabouis G, et al: A phase II study of Navelbine (vinorelbine) in the treatment of non-small-cell lung cancer. Am J Clin Oncol 14:115-119, 1991
32. O'Rourke M, Crawford J, Schiller J, et al: Survival advantage for patients with stage IV NSCLC treated with single agent Navelbine in a randomized controlled trial. Proc Am Soc Clin Oncol 12:343, 1993 (abstr 1148)
33. Yokoyama A, Furuse K, Niitani H, et al: Multi-institutional phase II study of navelbine (vinorelbine) in non-small-cell lung cancer Proc Am Soc Clin Oncol 11:287, 1992 (abstr 957)
34. Masters GA, Drinkard LC, Hoffman PC, et al: A phase I/ phase II study of vinorelbine (Navelbine) with cisplatin, 5-fluorouracil, and leucovorin for advanced non-small cell lung cancer. Cancer J Sci Am 1:288-294, 1995
35. Depierre A, Chastang C, Quoix E, et al: Efficacy of Navelbine (NVB) in non-small cell lung cancer. Ann Oncol 5:37-42, 1994
36. Vokes EE, Lyss AP, Herndon JE, et al: Intravenous 6-thioguanine or cisplatin, fluorouracil and leucovorin for advanced non-small cell lung cancer: A randomized phase II study of the Cancer and Leukemia Group B. Ann Oncol 3:727-732, 1992
37. Bryant BM, Jarman M, Ford HT, et al: Prevention of isophosphamide-induced urothelial toxicity with 2-mercaptoethane sulphonate sodium (mesnum) in patients with advanced carcinoma. Lancet 2:657-659, 1980
38. Sarosy G: Ifosfamide - Pharmacologic overview. Semin Oncol 16:2-8, 1989
39. Drings P: European experience with ifosfamide in non-small cell lung cancer. Semin Oncol 16:22-30, 1989
40. Beahrs OH, Henson DE, Hutter RVP, et al: Handbook for Staging of Cancer (ed 4). Philadelphia, PA, Lippincott, 1993
41. Jehl F, Quoix E, Leveque D, et al: Pharmacokinetics and preliminary metabolis fate of Navelbine in humans as determined by high performance liquid chromatography. Cancer Res 51:2073-2076, 1991
42. Marquet P, Laachairc G, Debord J, et al: Pharmacokinetics of vinorelbine in man. Eur J Clin Pharmacol 42:545-547, 1992
43. Lucas S, Donehower R, Rowinsky E, et al: Absolute bioavailability (ABA) and pharmacokinetics (PK) of weekly Navelbine (NVB) liquid-filled soft gelatine capsules at full therapeutic doses in patients with solid tumors. Ann Oncol 3:125, 1992 (suppl 1)
44. Leveque D, Jehl F, Quoix E, et al: Clinical pharmacokinetics of vinorelbine alone and combined with cisplatin. J Clin Pharmacol 32:1096-1098, 1992
45. Hoffman PC, Masters GA, Drinkard LC, et al: Ifosfamide plus paclitaxel in advanced non-small-cell lung cancer: A phase I study. Ann Oncol 7:314-316, 1996
46. Langer CJ, Leighton JC, Comis RL, et al: Paclitaxel and carboplatin in combination in the treatment of advanced non-small cell lung cancer: A phase II toxicity, response, and survival analysis. J Clin Oncol 13:1860-1870, 1995
47. Crawford J, O'Rourke MA, Herndon J, et al: Sequential trials of vinorelbine (Navelbine) with carboplatin in patients with advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 14:376, 1995 (abstr 1162)
48. Gralla RJ: Clinical experience with Navelbine and cisplatin; Navelbine and mitomycin. Presented at the Current Status of Navelbine in Non-Small Cell Lung Cancer investigator's meeting, Dallas, TX, November 11-14, 1993
49. Chang AY: Pilot study of combination chemotherapy with Navelbine and Taxol in lung and breast cancer patients. Presented at the Update on the Role of Navelbine in the Treatment of Non-Small Cell Lung Cancer investigator's forum, Tyson's Corner, VA, April 22, 1995
50. Masters G, Drinkard L, Hoffman P, et al: A phase I study of concomitant chemoradiotherapy with cisplatin and Navelbine for advanced malignancies of the chest. Proc Am Soc Clin Oncol 14:378, 1995 (abstr 1173)