Oxaliplatin or paclitaxel in patients with platinum-pretreated advanced ovarian cancer: A randomized phase II study of the European Organization for Research and Treatment of Cancer Gynecology Group - PubMed (original) (raw)
Clinical Trial
. 2000 Mar;18(6):1193-202.
doi: 10.1200/JCO.2000.18.6.1193.
J A Green, A J Lacave, N Reed, I Vergote, P Benedetti-Panici, A Bonetti, V Kristeller-Tome, C M Fernandez, D Curran, M Van Glabbeke, D Lacombe, M C Pinel, S Pecorelli
Affiliations
- PMID: 10715288
- DOI: 10.1200/JCO.2000.18.6.1193
Clinical Trial
Oxaliplatin or paclitaxel in patients with platinum-pretreated advanced ovarian cancer: A randomized phase II study of the European Organization for Research and Treatment of Cancer Gynecology Group
M J Piccart et al. J Clin Oncol. 2000 Mar.
Abstract
Purpose: This was a multicentric, open, randomized, phase II study of single-agent paclitaxel and oxaliplatin to evaluate the efficacy of oxaliplatin in a relapsing progressive ovarian cancer patient population and to analyze the safety profile and impact of both agents on quality of life, time to progression, and survival.
Patients and methods: Eighty-six patients with platinum-pretreated advanced ovarian cancer were randomly assigned to two arms: 41 received paclitaxel at 175 mg/m(2) over 3 hours every 3 weeks, and 45 received oxaliplatin at 130 mg/m(2) over 2 hours every 3 weeks. For inclusion, patients had to have a performance status of 0 to 2 and to have received at least one and no more than two prior cisplatin- and/or carboplatin-containing chemotherapy regimens within the last 12 months.
Results: Seven confirmed responses were observed in each arm, for an overall response rate in the total treated population of 17% (95% confidence interval [CI], 7% to 32%) in the paclitaxel arm and 16% (95% CI, 7% to 29%) in the oxaliplatin arm. Median time to progression was 14 weeks and 12 weeks, and overall survival was 37 weeks and 42 weeks in the paclitaxel and oxaliplatin arms, respectively. Among 63 patients with a 0- to 6-month progression-free, platinum-free interval, there were five objective responses with paclitaxel in 31 patients and two objective responses with oxaliplatin in 32 patients. Nine patients (22%) in the paclitaxel arm had grade 3 or 4 neutropenia (National Cancer Institute of Canada [NCIC] Common Toxicity Criteria). Two patients (4%) experienced grade 3 thrombocytopenia in the oxaliplatin arm. Maximum grade (grade 3) NCIC neurosensory toxicity was experienced by three patients (7%) in the paclitaxel arm and by four patients (9%) in the oxaliplatin arm.
Conclusion: Single-agent oxaliplatin at 130 mg/m(2) every 3 weeks is active with moderate toxicity in patients with cisplatin-/carboplatin-pretreated advanced ovarian cancer.
Similar articles
- Multicentre phase II study of oxaliplatin as a single-agent in cisplatin/carboplatin +/- taxane-pretreated ovarian cancer patients.
Dieras V, Bougnoux P, Petit T, Chollet P, Beuzeboc P, Borel C, Husseini F, Goupil A, Kerbrat P, Misset JL, Bensmaïne MA, Tabah-Fisch I, Pouillart P. Dieras V, et al. Ann Oncol. 2002 Feb;13(2):258-66. doi: 10.1093/annonc/mdf018. Ann Oncol. 2002. PMID: 11886003 Clinical Trial. - A phase II study of a paclitaxel and oxaliplatin combination in platinum-sensitive recurrent advanced ovarian cancer patients.
Viens P, Petit T, Yovine A, Bougnoux P, Deplanque G, Cottu PH, Delva R, Lotz JP, Belle SV, Extra JM, Cvitkovic E. Viens P, et al. Ann Oncol. 2006 Mar;17(3):429-36. doi: 10.1093/annonc/mdj097. Ann Oncol. 2006. PMID: 16500913 Clinical Trial. - The integration of paclitaxel and new platinum compounds in the treatment of advanced ovarian cancer.
Vermorken JB. Vermorken JB. Int J Gynecol Cancer. 2001;11 Suppl 1:21-30. doi: 10.1046/j.1525-1438.2001.11(suppl.1)sup1021.x. Int J Gynecol Cancer. 2001. PMID: 11488999 Review. - Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial.
Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Pignata S, et al. Lancet Oncol. 2014 Apr;15(4):396-405. doi: 10.1016/S1470-2045(14)70049-X. Epub 2014 Feb 28. Lancet Oncol. 2014. PMID: 24582486 Clinical Trial. - Medical therapy of advanced malignant epithelial tumours of the ovary.
Colombo N, Parma G, Bocciolone L, Franchi D, Sideri M, Maggioni A. Colombo N, et al. Forum (Genova). 2000 Oct-Dec;10(4):323-32. Forum (Genova). 2000. PMID: 11535983 Review.
Cited by
- Gemcitabine-oxaliplatin (GEMOX) as salvage treatment in pretreated epithelial ovarian cancer patients.
Vici P, Sergi D, Pizzuti L, Mariani L, Arena MG, Barba M, Maugeri-Saccà M, Vincenzoni C, Vizza E, Corrado G, Paoletti G, Tomao F, Tomao S, Giannarelli D, Di Lauro L. Vici P, et al. J Exp Clin Cancer Res. 2013 Aug 8;32(1):49. doi: 10.1186/1756-9966-32-49. J Exp Clin Cancer Res. 2013. PMID: 23927758 Free PMC article. Clinical Trial. - Evaluation of the cytotoxicity of the Bithionol-paclitaxel combination in a panel of human ovarian cancer cell lines.
Ayyagari VN, Diaz-Sylvester PL, Hsieh TJ, Brard L. Ayyagari VN, et al. PLoS One. 2017 Sep 20;12(9):e0185111. doi: 10.1371/journal.pone.0185111. eCollection 2017. PLoS One. 2017. PMID: 28931042 Free PMC article. - New drugs in gynecologic cancer.
Daud A, Munster P, Munster P, Spriggs DR. Daud A, et al. Curr Treat Options Oncol. 2001 Apr;2(2):119-28. doi: 10.1007/s11864-001-0054-0. Curr Treat Options Oncol. 2001. PMID: 12057130 Review. - Optimal chemotherapy treatment for women with recurrent ovarian cancer.
Fung-Kee-Fung M, Oliver T, Elit L, Oza A, Hirte HW, Bryson P. Fung-Kee-Fung M, et al. Curr Oncol. 2007 Oct;14(5):195-208. doi: 10.3747/co.2007.148. Curr Oncol. 2007. PMID: 17938703 Free PMC article. - Paclitaxel: a pharmacoeconomic review of its use in the treatment of ovarian cancer.
Young M, Plosker GL. Young M, et al. Pharmacoeconomics. 2001;19(12):1227-59. doi: 10.2165/00019053-200119120-00005. Pharmacoeconomics. 2001. PMID: 11772158 Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical