Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.

Timeline

Start

1998-03

Primary completion

2006-01

Completion

—

Outcome

Missed primary endpoint

paper the median duration of progression-free survival in the intravenous-therapy and intraperitoneal-therapy groups was 18.3 and 23.8 months, respectively (P=0.05 by the log-rank test). PMID 16394300 ↗

Publications

• Background Barlin JN, Dao F, Bou Zgheib N, Ferguson SE, Sabbatini PJ, Hensley ML, Bell-McGuinn KM, Konner J, Tew WP, Aghajanian C, Chi DS. Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer. Gynecol Oncol. 2012 Jun;125(3):621-4. doi: 10.1016/j.ygyno.2012.03.027. Epub 2012 Mar 21.
• Background Rubatt JM, Darcy KM, Tian C, Muggia F, Dhir R, Armstrong DK, Bookman MA, Niedernhofer LJ, Deloia J, Birrer M, Krivak TC. Pre-treatment tumor expression of ERCC1 in women with advanced stage epithelial ovarian cancer is not predictive of clinical outcomes: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):421-6. doi: 10.1016/j.ygyno.2012.01.008. Epub 2012 Jan 16.
• Background Tian C, Ambrosone CB, Darcy KM, Krivak TC, Armstrong DK, Bookman MA, Davis W, Zhao H, Moysich K, Gallion H, DeLoia JA. Common variants in ABCB1, ABCC2 and ABCG2 genes and clinical outcomes among women with advanced stage ovarian cancer treated with platinum and taxane-based chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Mar;124(3):575-81. doi: 10.1016/j.ygyno.2011.11.022. Epub 2011 Nov 21.
• Background Hamilton CA, Miller A, Miller C, Krivak TC, Farley JH, Chernofsky MR, Stany MP, Rose GS, Markman M, Ozols RF, Armstrong DK, Maxwell GL. The impact of disease distribution on survival in patients with stage III epithelial ovarian cancer cytoreduced to microscopic residual: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Sep;122(3):521-6. doi: 10.1016/j.ygyno.2011.04.041. Epub 2011 Jun 17.
• Background Aletti GD, Nordquist D, Hartmann L, Gallenberg M, Long HJ, Cliby WA. From randomized trial to practice: single institution experience using the GOG 172 i.p. chemotherapy regimen for ovarian cancer. Ann Oncol. 2010 Sep;21(9):1772-1778. doi: 10.1093/annonc/mdq025. Epub 2010 Feb 5.
• Background von Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022.
• Background Darcy KM, Tian C, Ambrosone CB, et al.: A Gynecologic Oncology Group study of associations between polymorphisms in ABC transporter genes (ABCB1, ABCC2, and ABCG2) and outcome in advanced stage epithelial ovarian cancer treated with platinum and taxane chemotherapy. [Abstract] J Clin Oncol 27 (Suppl 15): A-5567, 2009.
• Background Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482.
• Background Zorn KK, Tian C, McGuire WP, Hoskins WJ, Markman M, Muggia FM, Rose PG, Ozols RF, Spriggs D, Armstrong DK. The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer. 2009 Mar 1;115(5):1028-35. doi: 10.1002/cncr.24084.
• Background Havrilesky LJ, Secord AA, Darcy KM, Armstrong DK, Kulasingam S; Gynecologic Oncology Group. Cost effectiveness of intraperitoneal compared with intravenous chemotherapy for women with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2008 Sep 1;26(25):4144-50. doi: 10.1200/JCO.2007.13.1961.
• Background Bristow RE, Santillan A, Salani R, Diaz-Montes TP, Giuntoli RL 2nd, Meisner BC, Armstrong DK, Frick KD. Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol. 2007 Sep;106(3):476-81. doi: 10.1016/j.ygyno.2007.05.043. Epub 2007 Aug 3.
• Background Winter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7. doi: 10.1200/JCO.2006.10.2517.
• Background Alberts DS, Delforge A. Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol. 2006 Dec;33(6 Suppl 12):S8-17. doi: 10.1053/j.seminoncol.2006.11.003.
• Background Armstrong DK, Brady MF. Intraperitoneal therapy for ovarian cancer: a treatment ready for prime time. J Clin Oncol. 2006 Oct 1;24(28):4531-3. doi: 10.1200/JCO.2006.06.7140. No abstract available.
• Background Markman M. Clinical efficacy supporting the role of intraperitoneal drug delivery in the primary chemotherapeutic management of small-volume residual advanced ovarian cancer. Semin Oncol. 2006 Dec;33(6 Suppl 12):S3-7. doi: 10.1053/j.seminoncol.2006.11.002.
• Background Singhal P, Lele S. Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw. 2006 Oct;4(9):941-6. doi: 10.6004/jnccn.2006.0077.
• Background Baysal BE, DeLoia JA, Willett-Brozick JE, Goodman MT, Brady MF, Modugno F, Lynch HT, Conley YP, Watson P, Gallion HH. Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol. 2004 Oct;95(1):62-9. doi: 10.1016/j.ygyno.2004.07.015.
• Results Armstrong DK, Bundy BN, Baergen R, et al.: Randomized phase III study of intravenous (IV) paclitaxel and cisplatin versus IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-803, 2002.
• Results Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
• Results DeLoia JA, Krivak T, Darcy KM, et al.: Relationship between the C8092A polymorphisms in ERCC1 and clinical outcome in optimally-resected, stage III epithelial ovarian cancer treated with intraperitoneal or intravenous cisplatin and paclitaxel: a Gynecologic Oncology Group study. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-1674, 2007.
• Results Krivak TC, Darcy KM, Tian C, et al.: Relationship between polymorphisms in cordon 118 and C8092A in ERCC1 and clinical outcome in optimally-resected, stage III epithelial ovarian cancer treated with intraperitoneal or intravenous cisplatin and paclitaxel: a Gynecologic Oncology Group study. [Abstract] J Clin Oncol 25 (Suppl 18): A-21050, 733s, 2007.
• Results Krivak TC, Darcy KM, Tian C, Armstrong D, Baysal BE, Gallion H, Ambrosone CB, DeLoia JA; Gynecologic Oncology Group Phase III Trial. Relationship between ERCC1 polymorphisms, disease progression, and survival in the Gynecologic Oncology Group Phase III Trial of intraperitoneal versus intravenous cisplatin and paclitaxel for stage III epithelial ovarian cancer. J Clin Oncol. 2008 Jul 20;26(21):3598-606. doi: 10.1200/JCO.2008.16.1323.
• Results Krivak TC, Tian C, Rose GS, Armstrong DK, Maxwell GL. A Gynecologic Oncology Group Study of serum CA-125 levels in patients with stage III optimally debulked ovarian cancer treated with intraperitoneal compared to intravenous chemotherapy: an analysis of patients enrolled in GOG 172. Gynecol Oncol. 2009 Oct;115(1):81-85. doi: 10.1016/j.ygyno.2009.06.021. Epub 2009 Jul 12.
• Results Krivak T, Darcy K, Tian C, et al.: Relationship between polymorphisms in ERCC1 and clinical outcome in optimally resected stage III epithelial ovarian cancer: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-146, 2007.
• Results Seamon LG, Carlson MJ, Richardson DL, et al.: Improved intraperitoneal chemotherapeutic toxicity profile for ovarian cancer: A modification of the taxane-platinum protocol in GOG-172. [Abstract] J Clin Oncol 26 (Suppl 15): A-5583, 2008.
• Results Thrall M, Gallion HH, Kryscio R, Kapali M, Armstrong DK, DeLoia JA. BRCA1 expression in a large series of sporadic ovarian carcinomas: a Gynecologic Oncology Group study. Int J Gynecol Cancer. 2006 Jan-Feb;16 Suppl 1:166-71. doi: 10.1111/j.1525-1438.2006.00504.x.
• Results von Gruenigen VE, Huang HQ, Gil KM, Frasure HE, Armstrong DK, Wenzel LB. The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study. Gynecol Oncol. 2012 Mar;124(3):379-82. doi: 10.1016/j.ygyno.2011.11.032. Epub 2011 Nov 23.
• Results Walker JL, Armstrong D, Huang H, et al.: Intraperitoneal catheter outcomes on GOG 172: a Gynecologic Oncology Group study in women with optimally debulked stage III ovarian cancer. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-062, 19, 2004.
• Results Walker JL, Armstrong DK, Huang HQ, Fowler J, Webster K, Burger RA, Clarke-Pearson D. Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2006 Jan;100(1):27-32. doi: 10.1016/j.ygyno.2005.11.013.
• Results Wenzel LB, Huang HQ, Armstrong DK, et al.: Baseline quality of life (QOL) as a predictor of tolerance to intraperitoneal (IP) chemotherapy for advanced epithelial ovarian cancer (EOC): a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 24 (Suppl 18): A-5007, 257s, 2006.
• Results Wenzel LB, Huang HQ, Armstrong DK, Walker JL, Cella D; Gynecologic Oncology Group. Health-related quality of life during and after intraperitoneal versus intravenous chemotherapy for optimally debulked ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 1;25(4):437-43. doi: 10.1200/JCO.2006.07.3494.
• Results Wenzel L, Huang HQ, Cella D, Walker JL, Armstrong DK; Gynecologic Oncology Group. Validation of FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jul;110(1):60-4. doi: 10.1016/j.ygyno.2008.02.011. Epub 2008 Apr 21.

Drugs

Indications