Phase III Randomized Trial of Intravenous CDDP/CTX vs Intravenous CDDP/TAX vs Intravenous High-Dose CBDCA Followed by Intravenous TAX/Intraperitoneal CDDP in Patients with Optimal Stage III Ovarian Epithelial Cancer
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||GOG-0114|
I. Compare recurrence-free interval, pathologic complete response rate, and survival in patients with optimal Stage III ovarian epithelial cancer treated with intravenous cisplatin/cyclophosphamide vs. intravenous cisplatin/taxol vs. intravenous high-dose carboplatin followed by intravenous taxol/intraperitoneal cisplatin. II. Compare the toxicities and complications of these three regimens. III. Correlate serial serum CA-125 levels with findings at second-look laparotomy and recurrence-free interval.
Histologic diagnosis of epithelial ovarian carcinoma of one of the following histologies: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified Optimal Stage III disease, i.e., no greater than 1 cm in diameter following appropriate surgery Tissue for histologic evaluation required Entry required within 6 weeks of surgery No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Optimum debulking required
Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 x normal SGOT no greater than 3 x normal No acute hepatitis Renal: Creatinine clearance at least 50 ml/min Cardiovascular: No CHF No unstable angina No MI in the past 6 months No anticipated intolerance to sinus bradycardia No abnormal cardiac conduction: Bundle branch block Heart block No requirement for drugs that affect cardiac conduction: Propranolol Calcium channel blockers Lanoxin Other: No septicemia or severe infection No severe GI bleeding No condition that will interfere with completion of study or follow-up No prior or concurrent second malignancy except nonmelanomatous skin cancer
209 patients/arm will be entered in order to have 188 patients/arm complete therapy and undergo second-look surgery. As of 9/20/93, accrual to Arm I is closed, 290 patients have been entered, and an additional 150 patients will be randomized to Arms II and III over 7.5 months.
Randomized study. Arm I (closed as of 9/93): 2-Drug Combination Intravenous Chemotherapy. Cisplatin, CDDP, NSC-119875; Cyclophosphamide, CTX, NSC-26271. Arm II: 2-Drug Combination Intravenous Chemotherapy. CDDP; Taxol, TAX, NSC-125973. Arm III: Single-Agent Intravenous Chemotherapy followed by 2-Drug Combination Intravenous/Intraperitoneal Chemotherapy. Carboplatin, CBDCA, NSC-241240; followed by intravenous TAX; intraperitoneal CDDP.
Gardner GJ, Baser RE, Brady MF, et al.: CA125 regression in ovarian cancer patients treated with intravenous versus intraperitoneal platinum-based chemotherapy: a gynecologic oncology group study. Gynecol Oncol 124 (2): 216-20, 2012.[PUBMED Abstract]
Markman M, Bundy BN, Alberts DS, et al.: Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol 19 (4): 1001-7, 2001.[PUBMED Abstract]
Markman M, Bundy B, Benda J, et al.: Randomized phase 3 study of intravenous (IV) cisplatin (CIS)/paclitaxel (PAC) versus moderately high dose IV carboplatin (CARB) followed by IV PAC and intraperitoneal (IP) CIS in optimal residual ovarian cancer (CC): An intergroup trial (GOG,SWOG, ECOG). [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1392, 361a, 1998.
Alvarez Secord A, Darcy KM, Hutson A, et al.: The regulation of MASPIN expression in epithelial ovarian cancer: association with p53 status, and MASPIN promoter methylation: a gynecologic oncology group study. Gynecol Oncol 123 (2): 314-9, 2011.[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]
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]
Jewell EL, Darcy KM, Hutson A, et al.: Association between the N-terminally truncated (DeltaN) p63alpha (DeltaNp63alpha) isoform and debulking status, VEGF expression and progression-free survival in previously untreated, advanced stage epithelial ovarian cancer: A Gynecologic Oncology Group study. Gynecol Oncol 115 (3): 424-9, 2009.[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]
Havrilesky L, Fleming ND, Miner Z, et al.: Correlations between cell cycle regulatory genes and relationship to ovarian cancer prognosis: 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-299, 2007.
Secord AA, Darcy KM, Hutson A, et al.: Co-expression of angiogenic markers and associations with prognosis in advanced epithelial ovarian cancer: a Gynecologic Oncology Group study. Gynecol Oncol 106 (1): 221-32, 2007.[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]
Alberts DS, Delforge A: Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol 33 (6 Suppl 12): S8-17, 2006.[PUBMED Abstract]
Secord AA, Lee PS, Darcy KM, et al.: Maspin expression in epithelial ovarian cancer and associations with poor prognosis: a Gynecologic Oncology Group study. Gynecol Oncol 101 (3): 390-7, 2006.[PUBMED Abstract]
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 33 (6 Suppl 12): S3-7, 2006.[PUBMED Abstract]
Secord AA, Darcy K, Hutson A, et al.: The role of methylation in the regulation of angiogenic inhibitors in advanced ovarian cancer: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-192, 2006.
Singhal P, Lele S: Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw 4 (9): 941-6, 2006.[PUBMED Abstract]
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]
Havrilesky LJ, Alvarez AA, Whitaker R, et al.: Loss of expression of the P16 tumor suppressor gene is more frequent in advanced ovarian cancers lacking P53 mutations. [Abstract] Society of Gynecologic Oncologists 2004 Annual Meeting on Women's Cancer, 7-11 February 2004, San Diego, California. A-814, 2004.
Trial Contact Information
Trial Lead Organizations
Gynecologic Oncology Group
Ph: 216-445-6888; 800-862-7798
Southwest Oncology Group
Eastern Cooperative Oncology Group
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.