Phase III Randomized Study of Platinum Compound and Paclitaxel in Optimal Stage III Ovarian Epithelial Cancer: Cisplatin and Paclitaxel (24-Hour Continuous Infusion) vs Carboplatin and Paclitaxel (3-Hour Infusion)
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||GOG-0158|
I. Compare the recurrence-free interval and survival in patients with optimal stage III (i.e., no greater than 1 cm in diameter) ovarian epithelial cancer randomized to cisplatin and paclitaxel (Taxol) administered as a 24-hour continuous infusion vs. carboplatin and paclitaxel administered as a 3-hour infusion. II. Compare the toxic effects and complications of the 2 treatment regimens. III. Correlate serial serum CA 125 levels with recurrence-free interval. IV. Determine platinum-DNA adduct levels in the peripheral leukocytes of patients receiving platinum-based chemotherapy as first line therapy and to correlate platinum DNA adduct formation with response to therapy.
Histologically diagnosed ovarian epithelial carcinoma Optimal stage III disease, i.e.: Residual disease no greater than 1 cm in diameter following appropriate cytoreductive surgery Node dissection not required for stage IIIC disease with residual, measurable, palpable disease less than 1 cm The following histologies are eligible: Serous adenocarcinoma Adenocarcinoma NOS Mucinous adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated carcinoma Transitional cell Mixed epithelial carcinoma Malignant Brenner's tumor No borderline carcinoma Patients eligible for this protocol are also eligible for protocol GOG-118
No prior radiotherapy or chemotherapy No more than 6 weeks since surgery
Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No unstable angina No myocardial infarction within 6 months Abnormal cardiac conduction (e.g., bundle branch or heart block) allowed if stable for the past 6 months Other: No severe infection, including septicemia No severe gastrointestinal bleeding No history of second malignancy within 5 years except nonmelanomatous skin cancer
720 patients will be accrued.
Randomized study. The following acronyms are used: CBDCA Carboplatin, NSC-241240 CDDP Cisplatin, NSC-119875 TAXOL Paclitaxel (Bristol-Myers), NSC-125973 Arm I: 2-Drug Combination Chemotherapy. Taxol/CDDP. 24-hour continuous infusion of Taxol. Arm II: 2-Drug Combination Chemotherapy. Taxol/CBDCA. 3-hour infusion of Taxol.
Bodurka DC, Deavers MT, Tian C, et al.: Reclassification of serous ovarian carcinoma by a 2-tier system: a Gynecologic Oncology Group Study. Cancer 118 (12): 3087-94, 2012.[PUBMED Abstract]
Wright JD, Tian C, Mutch DG, et al.: Carboplatin dosing in obese women with ovarian cancer: a Gynecologic Oncology Group study. Gynecol Oncol 109 (3): 353-8, 2008.[PUBMED Abstract]
Darcy KM, Tian C, Reed E: A Gynecologic Oncology Group study of platinum-DNA adducts and excision repair cross-complementation group 1 expression in optimal, stage III epithelial ovarian cancer treated with platinum-taxane chemotherapy. Cancer Res 67 (9): 4474-81, 2007.[PUBMED Abstract]
Hess LM, Barakat R, Tian C, et al.: Weight change during chemotherapy as a potential prognostic factor for stage III epithelial ovarian carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 107 (2): 260-5, 2007.[PUBMED Abstract]
Wright JD, Tian C, Mutch DG, et al.: Carboplatin dosing in obese women with 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-38, 2007.
Hess LM, Tian C, Barakat R, et al.: Change in patient weight during platinum/paclitaxel-based chemotherapy for ovarian cancer: a Gynecologic Oncology Group study. [Abstract] J Clin Oncol 24 (Suppl 18): A-5073, 273s, 2006.
Burger RA, Darcy KM, DiSaia PJ, et al.: Association between serum levels of soluble tumor necrosis factor receptors/CA 125 and disease progression in patients with epithelial ovarian malignancy: a gynecologic oncology group study. Cancer 101 (1): 106-15, 2004.[PUBMED Abstract]
Ozols RF, Bundy BN, Fowler JM, et al.: Randomized phase III study of cisplatin (CIS)/paclitaxel (PAC) versus Carboplatin (CARBO)/PAC in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 158). [Abstract] Society of Gynecologic Oncologists 2003 Annual Meeting on Women's Cancer, January 31 - February 2, 2003, New Orleans, Louisiana. A-285, 2003.
Ozols RF, Bundy BN, Fowler J, et al.: Randomized phase III study of cisplatin (CIS)/paclitaxel (PAC) versus carboplatin (CARBO)/PAC in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 158). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-1373, 356a, 1999.
Bookman MA, Greer BE, Ozols RF: Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. Int J Gynecol Cancer 13 (6): 735-40, 2003 Nov-Dec.[PUBMED Abstract]
Bristow RE, Santillan A, Salani R, et al.: Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol 106 (3): 476-81, 2007.[PUBMED Abstract]
Farley JH, Tian C, Rose GS, et al.: Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer 115 (18): 4210-7, 2009.[PUBMED Abstract]
Hamilton CA, Miller A, Miller C, et al.: 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 122 (3): 521-6, 2011.[PUBMED Abstract]
Havrilesky LJ, Secord AA, Darcy KM, et al.: 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 26 (25): 4144-50, 2008.[PUBMED Abstract]
Winter WE 3rd, Maxwell GL, Tian C, et al.: Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (24): 3621-7, 2007.[PUBMED Abstract]
Zorn KK, Tian C, McGuire WP, et al.: The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer 115 (5): 1028-35, 2009.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Gynecologic Oncology Group
Ph: 215-728-2673; 888-369-2427
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.