Limited access trial using amifostine for protection against cisplatin- and three-hour paclitaxel-induced neurotoxicity: A phase II study of the Gynecologic Oncology Group

Journal of Clinical Oncology

Volumn 21, Issue 22, 2003, Pages 4207-4213

  Moore, David H ^b   Donnelly, James ^b   McGuire, William P ^b   Almadrones, Lois ^b   Cella, David F ^b   Herzog, Thomas J ^b   Waggoner, Steven E ^b   Mackey, Denise ^a  

^a Four Penn Center   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMIFOSTINE; CISPLATIN; PACLITAXEL; ANTINEOPLASTIC AGENT; RADIOPROTECTIVE AGENT;

ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFECT; FEMALE; HUMAN; NEUROPROTECTION; NEUROTOXICITY; OUTCOME ASSESSMENT; OVARY CANCER; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUESTIONNAIRE; TREATMENT OUTCOME; VIBRATION SENSE; ADULT; AGED; BREAST TUMOR; CHEMICALLY INDUCED DISORDER; DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; NEUROLOGIC EXAMINATION; PATHOLOGY;

ADULT; AGED; AGED, 80 AND OVER; AMIFOSTINE; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CISPLATIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; NEUROLOGIC EXAMINATION; PACLITAXEL; PERIPHERAL NERVOUS SYSTEM DISEASES; RADIATION-PROTECTIVE AGENTS; TREATMENT OUTCOME;

EID: 0642347604     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.02.086     Document Type: Article

References (30)

1. Ehrlich CE, Einhorn L, Williams SD, et al: Chemotherapy for stage III-IV epithelial ovarian cancer with cis-dichlorodiammineplatinum (II), adriamycin, and cyclophosphamide: A preliminary report. Cancer Treat Rep 63:281-288, 1979
2. Omura GA, Blessing JA, Ehrlich CE, et al: A randomized trial of cyclophosphamide and doxorubicin with or without cisplatin in advanced ovarian carcinoma: A Gynecologic Oncology Group study. Cancer 57:1725-1730, 1986
3. Neijt JP, ten Bokkel Huinink WW, van der Burg ME, et al: Randomised trial comparing two combination chemotherapy regimens (Hexa-CAF vs CHAP-5) in advanced ovarian carcinoma. Lancet 2:594-600, 1984
4. Advanced Ovarian Cancer Trialists Group: Chemotherapy in advanced ovarian cancer: An overview of randomized clinical trials. BMJ 303:884-893, 1991
5. Donehower RC, Rowinsky EK, Grochow LB, et al: Phase I trial of taxol in patients with advanced cancer. Cancer Treat Rep 71:1171-1177, 1987
6. Trimble EL, Adams JD, Vena D, et al: Paclitaxel for platinum-refractory ovarian cancer: Results from the first 1,000 patients registered to National Cancer Institute Treatment Referral Center 9103. J Clin Oncol 11:2405-2410, 1993
7. Rowinsky EK, Gilbert MR, McGuire WP, et al: Sequences of taxol and cisplatin: A phase I and pharmacologic study. J Clin Oncol 9:1692-1703, 1991
8. McGuire WP, Hoskins WJ, Brady MF, et al: Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and IV ovarian cancer. N Engl J Med 334:1-6, 1996
9. Lo Monaco M, Milone M, Batocchi AP, et al: Cisplatin neuropathy: Clinical course and neurophysiological findings. J Neurol 239:199-204, 1992
10. Rowinsky EK, Donehower RC: Paclitaxel (Taxol). N Engl J Med 332:1004-1014, 1995
11. Sarosy G, Kohn E, Stone DA, et al: Phase I study of taxol and granulocyte colony-stimulating factor in patients with refractory ovarian cancer. J Clin Oncol 10:1165-1170, 1992
12. 2): Unexpected high incidence of peripheral neuropathy. Gynecol Oncol 60:98-99, 1996 (abstr 8)
13. Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, et al: European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: High-dose versus low-dose and long versus short infusion. J Clin Oncol 12:2654-2666, 1994
14. Piccart MJ, Bertelsen K, James K, et al: Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: Three-year results. J Natl Cancer Inst 92:699-708, 2000
15. Yuhas JM, Culo F: Selective inhibition of the nephrotoxicity of cis-DDP by WR-2721 without altering its antitumor properties. Cancer Treat Rep 64:57-64, 1980
16. Muller LJ, Moorer-van Delft CM, Roubos WE, et al: Quantitative ultrastructural effects of cisplatin (Platinol), carboplatin (JM8), and iproplatin (JM9) on neurons of freshwater snail Lymnaea stagnalis. Cancer Res 52:963-973, 1992
17. Mollman JE, Glover DJ, Hogan WM, et al: Cisplatin neuropathy: Risk factors, prognosis, and protection by WR-2721. Cancer 61:2192-2195, 1988
18. Rose P, Kemp G, Glick J: Ethyol (amifostine) protects against cumulative cisplatin toxicities. Proc Am Soc Clin Oncol 15:533, 1996 (abstr 1724)
19. Cella D: F. A. C. I. T. Manual: Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Scales (version 4). Evanston, IL, Center on Outcomes, Research and Education (CORE), Evanston Northwestern Healthcare and Northwestern University, 1997
20. Cella D, Peterman A, Hudgens S, et al: Measuring the side effects of taxane therapy in oncology: The Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane). Cancer 98:822-831, 2003
21. Calhoun EA, Welshman EE, Chang C-H, et al: Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer (in press)
22. Hay JW: Quality of life effects of chemotherapy-induced neuropathy in ovarian cancer. Proc Am Soc Clin Oncol 21:222, 2002 (abstr 886)
23. Vasey PA: Survival and longer-term toxicity results of the SCOTROC study: Docetaxel-carboplatin vs. paclitaxel-carboplatin in epithelial ovarian cancer-Scottish Gynaecological Cancer Trials Group. Proc Am Soc Clin Oncol 21:202a, 2002 (abstr 804)
24. Glover D, Glick J, Weiler C, et al: Phase I trials of WR-2721 and cis-platinum. Int J Radiat Oncol Biol Phys 10:1781-1784, 1984
25. Glover D, Glick JH, Weiler C, et al: Phase I/II trials of WR-2721 and cis-platinum. Int J Radiat Oncol Biol Phys 12:1509-1512, 1986
26. Glover D, Glick J, Weiler C, et al: WR-2721 and high-dose cisplatin: An active combination in the treatment of metastatic melanoma. J Clin Oncol 5:574-578, 1987
27. Kemp G, Rose P, Lurain J, et al: Amifostine pretreatment for protection against cyclophosphamide-induced and cisplatin-induced toxicities: Results of a randomized control trial in patients with advanced ovarian cancer. J Clin Oncol 14:2101-2112, 1996
28. Postma TH, Heimans JJ, Muller MJ, et al: Pitfalls in grading severity of chemotherapy-induced peripheral neuropathy. Ann Oncol 9:739-744, 1998
29. Cassidy J, Paul J, Soukop M, et al: Clinical trials of nimodipine as a potential neuroprotector in ovarian cancer patients treated with cisplatin. Cancer Chemother Pharmacol 41:161-166, 1998
30. Peltier AC, Russell JW: Recent advances in drug-induced neuropathies. Curr Opin Neurol 15:633-638, 2002