Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: A phase III trial of the gynecologic cancer intergroup

Journal of Clinical Oncology

Volumn 27, Issue 9, 2009, Pages 1419-1425

  Bookman, Michael A ^a   Brady, Mark F ^b   McGuire, William P ^b   Harper, Peter G ^b   Alberts, David S ^b   Friedlander, Michael ^b   Colombo, Nicoletta ^b   Fowler, Jeffrey M ^b   Argenta, Peter A ^b   De Geest, Koen ^b   Mutch, David G ^b   Burger, Robert A ^b   Swart, Ann Marie ^b   Trimble, Edward L ^b   Accario Winslow, Chrisann ^b   Roth, Lawrence M ^b  

^a FOX CHASE CANCER CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; CARBOPLATIN; DOXORUBICIN; GEMCITABINE; HEMOGLOBIN; METHOXYPOLYETHYLENE GLYCOSYLATED LIPOSOMAL DOXORUBICIN; PACLITAXEL; TOPOTECAN; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; MACROGOL DERIVATIVE;

ADULT; ADVANCED CANCER; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOREDUCTIVE SURGERY; EVALUATION; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; LIVER TOXICITY; LUNG TOXICITY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVARY CARCINOMA; PERIPHERAL NEUROPATHY; PERITONEUM CANCER; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR VOLUME; DISEASE FREE SURVIVAL; MIDDLE AGED; OVARY TUMOR; PATHOLOGY; PERITONEUM TUMOR;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM STAGING; OVARIAN NEOPLASMS; PACLITAXEL; PERITONEAL NEOPLASMS; POLYETHYLENE GLYCOLS; TOPOTECAN;

EID: 63049115790     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.19.1684     Document Type: Article

References (32)

1. ten Bokkel Huinink W, Lane SR, Ross GA, et al: Long-term survival in a phase III, randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma. Ann Oncol 15:100-103, 2004
2. Gordon AN, Tonda M, Sun S, et al: Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol 95:1-8, 2004
3. Pfisterer J, Plante M, Vergote I, et al: Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: An intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol 24:4699-4707, 2006
4. Greer BE, Bundy BN, Ozols RF, et al: Implications of second-look laparotomy in the context of optimally resected stage III ovarian cancer: A nonrandomized comparison using an explanatory analysis: A Gynecologic Oncology Group study. Gynecol Oncol 99:71-79, 2005
5. Rustin GJ, Timmers P, Nelstrop A, et al: Comparison of CA-125 and standard definitions of progression of ovarian cancer in the intergroup trial of cisplatin and paclitaxel versus cisplatin and cyclophosphamide. J Clin Oncol 24:45-51, 2006
6. Look KY, Bookman MA, Schol J, et al: Phase I feasibility trial of carboplatin, paclitaxel, and gemcitabine in patients with previously untreated epithelial ovarian or primary peritoneal cancer: A Gynecologic Oncology Group study. Gynecol Oncol 92:93-100, 2004
7. Iaffaioli RV, Tortoriello A, Facchini G, et al: Phase I/II study of gemcitabine and carboplatin in stages IIIB to IV non-small-cell lung cancer. J Clin Oncol 17:921-926, 1999
8. Bookman MA, McMeekin DS, Fracasso PM: Sequence dependence of hematologic toxicity using carboplatin and topotecan for primary therapy of advanced epithelial ovarian cancer: A phase I study of the Gynecologic Oncology Group. Gynecol Oncol 103:473-478, 2006
9. Armstrong DK, Bookman MA, McGuire W, et al: A phase I study of paclitaxel, topotecan, cisplatin and Filgrastim in patients with newly diagnosed advanced ovarian epithelial malignancies: A Gynecologic Oncology Group study. Gynecol Oncol 105: 667-671, 2007
10. Rose PG, Greer BE, Horowitz IR, et al: Paclitaxel, carboplatin and pegylated liposomal doxorubicin in ovarian and peritoneal carcinoma: A phase I study of the Gynecologic Oncology Group. Gynecol Oncol 104:114-119, 2007
11. Royston P, Parmar MKB, Qian W: Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer. Stat Med 22:2239-2256, 2003
12. Peto R, Peto J: Asymptotically efficient rank invariant procedures. J Roy Stat Soc A 135:185-206, 1972; discussion 199-206
13. Schoenfeld D: The asymptotic properties of the nonparametric tests for comparing survival distributions. Biometika 68:316-319, 1981
14. McGuire WP, Hoskins WJ, Brady MF, 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
15. 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
16. Piccart MJ, Bertelsen K, Stuart G, et al: Long-term follow-up confirms a survival advantage of the paclitaxel-cisplatin regimen over the cyclophosphamide-cisplatin combination in advanced ovarian cancer. Int J Gynecol Cancer 13:144-148, 2003 (suppl 2)
17. Kyrgiou M, Salanti G, Pavlidis N, et al: Survival benefits with diverse chemotherapy regimens for ovarian cancer: Meta-analysis of multiple treatments. J Natl Cancer Inst 98:1655-1663, 2006
18. Ozols RF, Bundy BN, Greer BE, et al: Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: A Gynecologic Oncology Group study. J Clin Oncol 21:3194-3200, 2003
19. du Bois A, Luck HJ, Meier W, et al: Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer Study Group: A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95:1320-1329, 2003
20. du Bois A, Quinn M, Thigpen T, et al: Final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol 16:viii7-viii12, 2005 (suppl 8)
21. Muggia FM, Braly PS, Brady MF, et al: Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: A Gynecologic Oncology Group study. J Clin Oncol 18:106-115, 2000
22. The International Collaborative Ovarian Neoplasm (ICON) Group. Paclitaxel plus carboplatin versus standard chemotherapy with either single-agent carboplatin or cyclophosphamide, doxorubicin, and cisplatin in women with ovarian cancer: The ICON3 randomised trial. Lancet 360:505-515, 2002
23. Vasey PA, Jayson GC, Gordon A, et al: Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst 96:1682-1691, 2004
24. du Bois A, Belau A, Wagner U, et al: A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). Gynecol Oncol 96:444-451, 2005
25. Hansen SW: Gemcitabine, platinum, and paclitaxel regimens in patients with advanced ovarian carcinoma. Semin Oncol 29:17-19, 2002 (suppl 1)
26. Trimble EL, Davis J, DiSaia P, et al: Clinical trials in gynecological cancer. Int J Gynecol Cancer 17:547-556, 2007
27. Vermorken JB, Avall-Lundqvist E, Pfisterer J, Bacon M: The Gynecologic Cancer Intergroup (GCIG): history and current status. Ann Oncol 16: viii39-viii42, 2005 (suppl 8)
28. du Bois A, Weber B, Rochon J, et al: Addition of epirubicin as a third drug to carboplatin-paclitaxel in first-line treatment of advanced ovarian cancer: A prospectively randomized gynecologic cancer intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens. J Clin Oncol 24:1127-1135, 2006
29. Kristensen GB, Vergote I, Stuart G, et al: First-line treatment of ovarian cancer FIGO stages IIb-IV with paclitaxel/epirubicin/carboplatin versus paclitaxel/carboplatin. Int J Gynecol Cancer 13:172-177, 2003 (suppl 2)
30. Scarfone G, Scambia G, Raspagliesi F, et al: A multicenter, randomized, phase III study comparing paclitaxel/carboplatin (PC) versus topotecan/paclitaxel/carboplatin (TPC) in patients with stage III (residual tumor > 1 cm after primary surgery) and IV ovarian cancer (OC). J Clin Oncol 24:5003, 2006 (suppl 18S)
31. Hoskins PJ, Vergote I, Stuart G, et al: A phase III trial of cisplatin plus topotecan followed by paclitaxel plus carboplatin versus standard carboplatin plus paclitaxel as first-line chemotherapy in women with newly diagnosed advanced epithelial ovarian cancer (EOC) (OV. 16): A Gynecologic Cancer Intergroup Study of the NCIC CTG, EORTC GCG, and GEICO. J Clin Oncol 26:294s, 2008 (suppl; abstr LBA5505)
32. Burger RA, Sill M, Monk BJ, et al: Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: A Gynecologic Oncology Group Study. J Clin Oncol 25: 5165-5171, 2007