Phase III Randomized Study of TAX/CBDCA vs CBDCA or CAP (CTX/DOX/CDDP) for Advanced Ovarian Cancer
Chemotherapy in Treating Women With Advanced Ovarian Cancer
Basic Trial Information
|Phase III||Treatment||Closed||any age||MRC-ICON3|
I. Compare the overall and progression-free survival and complete response rate in women with advanced ovarian cancer treated with paclitaxel/carboplatin vs. a control arm of carboplatin or CAP (cyclophosphamide, doxorubicin, cisplatin) as first-line therapy. II. Assess patient quality of life in relation to treatment-related toxicity and anxiety and depression. III. Compare treatment costs during the first 6 months of study.
Histologically and clinically diagnosed invasive epithelial ovarian carcinoma
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Recommended minimum surgical procedures (if possible): Total hysterectomy and bilateral salpingo-oophorectomy (as appropriate) Omentectomy
Age: Not specified Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 x normal Renal: Not specified Other: No sepsis No contraindication to platinum-based chemotherapy
A maximum of 2,000 patients will be entered.
Randomized study. Patients are randomized 1:2 to Arms I and II. The choice of control treatment on Arm II must be made prior to randomization and is at the discretion of the investigator and the patient. The following acronyms are used: CAP CTX/DOX/CDDP CBDCA Carboplatin, NSC-241240 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 TAX Paclitaxel (Bristol-Myers Squibb), NSC-125973 Arm I: 2-Drug Combination Chemotherapy. TAX/CBDCA. Arm II: Single-Agent or 3-Drug Combination Chemotherapy. CBDCA or CAP.
Colombo N: Randomised trial of paclitaxel (PTX) and carboplatin (CBDCA) versus a control arm of carboplatin or CAP (cyclophosphamide, doxorubicin & cisplatin): The Third International Collaborative Ovarian Neoplasm study (ICON3). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1500, 2000.
Harper P: A Randomised Comparison of Paclitaxel (T) and Carboplatin (J) Versus a Control Arm of Single Agent Carboplatin (J) or CAP (cyclophosphamide, Doxorubicin and Cisplatin): 2075 Patients Randomised Into the 3rd International Collaborative Ovarian Neoplasm Study (ICON3) (Meeting abstract). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-1375, 1999.
Poole CJ: A randomised comparison of paclitaxel (T) and carboplatin (J) versus a control arm of single agent carboplatin (J) or cyclophosphamide, doxorubicin and cisplatin (CAP): 2074 patients randomised into the 3rd International Collaborative Ovarian Neoplasm study (ICON3). [Abstract] Br J Cancer 80 (suppl 2): A-2.11, 14, 1999.
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]
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]
Trial Contact Information
Trial Lead Organizations
Medical Research Council Clinical Trials Unit
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.