Phase III trial of paclitaxel at two dose levels, the higher dose accompanied by filgrastim at two dose levels in platinum-pretreated epithelial ovarian cancer: An intergroup study

Journal of Clinical Oncology

Volumn 21, Issue 15, 2003, Pages 2843-2848

  Omura, George A ^a   Brady, Mark F ^a   Look, Katherine Y ^a   Averette, Hervy E ^a   Delmore, James E ^a   Long, Harry J ^a   Wadler, Scott ^a   Spiegel, Gregory ^a   Arbuck, Susan G ^a  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; ANTINEOPLASTIC AGENT; PLATINUM DERIVATIVE;

ARTICLE; CANCER GROWTH; CANCER RECURRENCE; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE INCREASE; DRUG MEGADOSE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MONOTHERAPY; MYALGIA; NEUROPATHY; OVARY CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TREATMENT RESPONSE; ADULT; AGED; CHEMICALLY INDUCED DISORDER; DISEASE COURSE; MIDDLE AGED; MULTICENTER STUDY; NEUTROPENIA; OVARY TUMOR; PATHOLOGY; PROPORTIONAL HAZARDS MODEL; STATISTICAL MODEL; SURVIVAL; TUMOR RECURRENCE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FILGRASTIM; HUMANS; LOGISTIC MODELS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEUTROPENIA; OVARIAN NEOPLASMS; PACLITAXEL; PLATINUM COMPOUNDS; PROPORTIONAL HAZARDS MODELS; SURVIVAL ANALYSIS;

EID: 0041384506     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.10.082     Document Type: Article

References (17)

1. McGuire WP III, Hoskins WJ, Brady M, et al: Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 334:1-6, 1996
2. Kohn EC, Sorosy G, Bicher A, et al: Dose-intense Taxol: High response rate in patients with platinum-resistant recurrent ovarian cancer. J Natl Cancer Inst 86:18-24, 1994
3. Crawford J, Ozer H, Stoller R, et al: Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small cell lung cancer. N Engl J Med 325:164-170, 1991
4. Blessing JA: Design, analysis and interpretation of chemotherapy trials in gynecologic cancer, in Deppe G (ed): Chemotherapy of Gynecologic Cancer (ed 2). New York, NY, Alan R Liss, Inc, Scientific and Medical Publications, 1990, pp 63-97
5. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
6. 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
7. Smith RE, Brown AM, Mamounas EP, et al: Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26. J Clin Oncol 17:3403-3411, 1999
8. Winer E, Berry D, Duggan D, et al: Failure of higher dose paclitaxel to improve outcome in patients with metastatic breast cancer: Results from CALGB 9342. Proc Am Soc Clin Oncol 17:101a, 1998 (abstr 388)
9. Nabholtz JM, Gelmon K, Bontenbal M, et al: Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol 14:1858-1867, 1996
10. Kosmidis P, Mylonakis N, Skarlos D, et al: Paclitaxel(175 mg/m2) plus carboplatin versus paclitaxel (225 mg/m2) plus carboplatin in advanced non-small-cell lung cancer (NSCLC): A multicenter randomized trial-Hellenic Cooperative Oncology Group (HeCOG). Ann Oncol 11:799-805, 2000
11. Bonomi P, Kim K, Fairclough D, et al: Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: Results of an Eastern Cooperative Oncology Group trial. J Clin Oncol 18:623-631, 2000
12. Stahel RA, Jost LM, Honegger H, et al: Randomized trial showing equivalent efficacy of filgrastim 5 mcg/kg/d and 10 mcg/kg/d following high-dose chemotherapy and autologous bone marrow transplantation in high-risk lymphomas. J Clin Oncol 15:1730-1735, 1997
13. Engelhardt M, Bertz H, Afting M, et al: High- versus standard-dose filgrastim for mobilization of peripheral-blood progenitor cells from allogeneic donors and CD34+ immunoselection. J Clin Oncol 17:2160-2172, 1999
14. Weaver CH, Birch R, Greco FA, et al: Mobilization and harvesting of peripheral blood stem cells: Randomized evaluations of different doses of filgrastim. Br J Haematol 100:338-347, 1998
15. Viens P, Chabannon C, Pouillard P, et al: Randomized, controlled, dose-range study of Ro 25-8315 given before and after a high-dose combination chemotherapy regimen in patients with metastatic or recurrent breast cancer patients. J Clin Oncol 20:24-36, 2002
16. Holmes FA, O'Shaughnessy JA, Vukelja S, et al: Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20:727-731, 2002
17. Omura GA, Brady MF, Homesley H, et al: Long follow-up and prognostic factor analysis in advanced ovarian carcinoma: The Gynecologic Oncology Group experience. J Clin Oncol 9:1138-1150, 1991