Phase III Randomized Study of CDDP vs TAX vs CDDP/TAX in Patients with Suboptimal Stage III/IV Ovarian Epithelial Carcinoma
Basic Trial Information
|Phase III||Treatment||Completed||any age||NCI||GOG-132|
I. Determine the relative efficacy of cisplatin (CDDP) vs. taxol (TAX) vs. CDDP/TAX in women with suboptimal Stage III/IV epithelial ovarian cancer following appropriate surgery. II. Determine the most favorable regimen in terms of progression-free and overall survival. III. Compare the incidence of ototoxicity and other toxicities arising from any of these three regimens.
Histologically confirmed, primary, Stage III/IV ovarian epithelial cancer of one of the following histologies: Serous adenocarcinoma Undifferentiated carcinoma Mucinous adenocarcinoma Mixed epithelial carcinoma Clear cell adenocarcinoma Malignant Brenner's tumor Endometrioid adenocarcinoma Transitional cell carcinoma Adenocarcinoma - NOS Disease must be suboptimal (greater than 1 cm in diameter) following appropriate surgery (at a minimum, exploratory laparotomy) Protocol entry within 6 weeks of surgery required Measurable disease preferred but not required Cytologic confirmation required if malignant pleural effusion is the sole disease manifestation No borderline carcinoma No unclassified ovarian cancer (i.e., patient not explored or verification of ovarian stromal origin not possible)
Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy for cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Exploratory laparotomy and appropriate surgical debulking required within 6 weeks of entry
Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 AGC at least 1,500 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 no greater than 2.0 mg/dl Cardiovascular: No history of CHF No unstable angina No MI within the past 6 months No history of arrhythmia or requirement for antiarrhythmic agents Other: No septicemia or severe infection No severe GI bleeding No prior or concomitant second malignancy except nonmelanomatous skin cancer
600 patients will be accrued over an estimated 30 months. After 50 failures are reported on Arm I, progression-free survival will be assessed; if at least 1 of the single-agent arms is clearly inferior to the combination arm, accrual to the least effective arm will cease.
Randomized study. Arm I: Single-agent Chemotherapy. Cisplatin, CDDP, NSC-119875. Arm II: Single-agent Chemotherapy. Taxol, TAX, NSC-125973. Arm III: 2-Drug Combination Chemotherapy. CDDP; TAX.
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 (1): 106-15, 2000.[PUBMED Abstract]
Muggia FM, Braly PS, Brady MF, et al.: Phase III of cisplatin (P) or paclitaxel (T), versus their combination in suboptimal stage III and IV epithelial ovarian cancer (EOC): Gynecologic Oncology Group (GOG) study #132. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-1257, 352a, 1997.
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]
Colombo N, Parma G, Bocciolone L, et al.: Medical therapy of advanced malignant epithelial tumours of the ovary. Forum (Genova) 10 (4): 323-32, 2000 Oct-Dec.[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]
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]
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.
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.
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]
Moss C, Kaye SB: Ovarian cancer: progress and continuing controversies in management. Eur J Cancer 38 (13): 1701-7, 2002.[PUBMED Abstract]
Muggia FM: Sequential single agents as first-line chemotherapy for ovarian cancer: a strategy derived from the results of GOG-132. Int J Gynecol Cancer 13 (Suppl 2): 156-62, 2003 Nov-Dec.[PUBMED Abstract]
Sandercock J, Parmar MK, Torri V: First-line chemotherapy for advanced ovarian cancer: paclitaxel, cisplatin and the evidence. Br J Cancer 78 (11): 1471-8, 1998.[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.
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]
Winter WE 3rd, Maxwell GL, Tian C, et al.: Tumor residual after surgical cytoreduction in prediction of clinical outcome in stage IV epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 26 (1): 83-9, 2008.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Gynecologic 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.