Phase III Comparison of CACP/CTX vs CACP/TAX in Patients with Suboptimal Stage III and Stage IV Epithelial Ovarian Carcinoma
Basic Trial Information
|Phase III||Treatment||Completed||18 and over||NCI||GOG-111|
I. Compare response rate, response duration, and survival of patients with suboptimal Stage III and Stage IV ovarian carcinoma randomly assigned to treatment with cisplatin/taxol vs. cisplatin/cyclophosphamide. II. Further evaluate the toxicities of cisplatin/taxol in this patient population. III. Compare the therapeutic index of these two combinations in patients with ovarian carcinoma.
Histologically documented suboptimal Stage III (i.e., greater than 1 cm in diameter) or Stage IV epithelial ovarian carcinoma The following histologies are acceptable: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Borderline carcinoma and "probably malignant" tumors are excluded Measurable disease preferred but not required Cytologic confirmation required if entry is based on malignant pleural effusion (35 mm slide of cytology specimen must be submitted) Postoperative CT scan required and report available at randomization for patients with nonmeasurable disease
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No more than 6 weeks beyond optimal surgery for ovarian cancer consisting minimally of exploratory laparotomy with biopsy and, when appropriate, TAH/BSO
Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin no more than 2 x normal SGOT no more than 2 x normal No acute hepatitis Renal: Creatinine no more than 2.0 mg/dl Cardiovascular: No current requirement for anti-arrhythmic medication No history of cardiac arrhythmia Other: No septicemia or severe infection No severe GI bleeding No second malignancy except nonmelanomatous skin cancer
It is estimated that a total of 360 patients will be entered over about 2.5 years.
Randomized study. Arm I: 2-Drug Combination Chemotherapy. Cisplatin, CACP, NSC-119875; Cyclophosphamide, CTX, NSC-26271. Arm II: 2-Drug Combination Chemotherapy. CACP; Taxol, TAX, NSC-125973.
Darcy KM, Brady WE, Blancato JK, et al.: Prognostic relevance of c-MYC gene amplification and polysomy for chromosome 8 in suboptimally-resected, advanced stage epithelial ovarian cancers: a Gynecologic Oncology Group study. Gynecol Oncol 114 (3): 472-9, 2009.[PUBMED Abstract]
Farley J, Fuchiuji S, Darcy KM, et al.: Associations between ERBB2 amplification and progression-free survival and overall survival in advanced stage, suboptimally-resected epithelial ovarian cancers: a Gynecologic Oncology Group Study. Gynecol Oncol 113 (3): 341-7, 2009.[PUBMED Abstract]
Farley J, Smith LM, Darcy KM, et al.: Cyclin E expression is a significant predictor of survival in advanced, suboptimally debulked ovarian epithelial cancers: a Gynecologic Oncology Group study. Cancer Res 63 (6): 1235-41, 2003.[PUBMED Abstract]
Farley JH, Smith LM, Darcy KM, et al.: Cyclin E expression is a significant predictor of decreased survival in advanced ovarian epithelial cancers: a Gynecologic Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-859, 2001.
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): 1-6, 1996.[PUBMED Abstract]
McGuire WP, Hoskins WJ, Brady MF, et al.: Taxol and cisplatin (TP) improves outcome in advanced ovarian cancer (AOC) as compared to cytoxan and cisplatin (CP). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-771, 275, 1995.
Farley J, Smith LM, Darcy KM, et al.: Nuclear P27 expression in benign, borderline (LMP) and invasive tumors of the ovary and its association with prognosis: a gynecologic oncology group study. Gynecol Oncol 121 (2): 395-401, 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]
Darcy KM, Brady WE, McBroom JW, et al.: Associations between p53 overexpression and multiple measures of clinical outcome in high-risk, early stage or suboptimally-resected, advanced stage epithelial ovarian cancers A Gynecologic Oncology Group study. Gynecol Oncol 111 (3): 487-95, 2008.[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]
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]
Almadrones L, McGuire DB, Walczak JR, et al.: Psychometric evaluation of two scales assessing functional status and peripheral neuropathy associated with chemotherapy for ovarian cancer: a gynecologic oncology group study. Oncol Nurs Forum 31 (3): 615-23, 2004.[PUBMED Abstract]
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 (9): 699-708, 2000.[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]
Meerpohl HG, du Bois A, Luck HJ, et al.: Paclitaxel combined with carboplatin in the first-line treatment of advanced ovarian cancer: a phase I trial. Semin Oncol 24 (1 Suppl 2): S2-17-S2-22, 1997.[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]
Trial Contact Information
Trial Lead Organizations
Gynecologic Oncology Group
Ph: 443-777-7826; 877-715-4673
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.