Phase III Randomized Study of TAX/CDDP vs CTX/CDDP in Patients with Advanced Epithelial Ovarian Cancer
Basic Trial Information
|Phase III||Treatment||Closed||no age specified||EORTC-55931|
CAN-NCIC-OV10, SCOTTISH-GYN-G42, SGCSG-NOCOVA-9410, OV10
I. Investigate whether progression-free survival is improved with first-line chemotherapy with paclitaxel/cisplatin compared to cyclophosphamide/cisplatin in patients with advanced ovarian cancer. II. Compare the clinical complete response rates, overall survival, qualitative and quantitative toxicities, quality of life, and cost effectiveness associated with the two regimens. III. Prospectively confirm that a CA-125 serum half-life less than 20 days or a 7-fold or greater fall in CA-125 in response to chemotherapy are predictions of improved survival.
Histologically confirmed epithelial ovarian carcinoma (by 1973 WHO histologic classification) FIGO Stage IIB/IIC/III/IV disease with or without successful debulking at staging laparotomy eligible No borderline ovarian tumors or abdominal adenocarcinoma of unknown origin No complete bowel obstruction No brain metastases
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No more than 8 weeks since initial surgery
Age: Not specified Performance status: WHO 0-3 Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.4 mg/dl (25 micromoles/liter) Renal: Creatinine no greater than 1.5 mg/dl (134 micromoles/liter) in patients weighing 45 kg or greater and no greater than 1.3 mg/dl (115 micromoles/liter) in patients weighing less than 45 kg OR Creatinine clearance at least 60 ml/min Cardiovascular: No MI within 6 months (unless only evidence is on pretreatment EKG) No history of CHF even if medically controlled No history of medically significant atrial or ventricular arrhythmia even if medically controlled Other: No active infection No prior allergic reaction to drugs containing Cremophor (e.g., cyclosporine or vitamin K) No other serious underlying medical condition that would preclude protocol therapy No second malignancy except adequately treated: Basal cell skin carcinoma In situ carcinoma of the cervix
Up to 600 patients will be accrued over 18-24 months.
Randomized study. Arm I: 2-Drug Combination Chemotherapy. CP: Cisplatin, CDDP, NSC-119875; Cyclophosphamide, CTX, NSC-26271. Arm II: 2-Drug Combination Chemotherapy. CDDP; Paclitaxel (Bristol-Myers), Taxol, TAX, NSC-125973.
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]
Piccart MJ, Bertelsen K, Stuart G, et al.: Long-term follow-up confirms a survival advantage of the paclitaxel-cisplatin regimen over the cyclophosphamide-cisplatin combination in advanced ovarian cancer. Int J Gynecol Cancer 13 (Suppl 2): 144-8, 2003 Nov-Dec.[PUBMED Abstract]
Carey MS, Bacon M, Tu D, et al.: The prognostic effects of performance status and quality of life scores on progression-free survival and overall survival in advanced ovarian cancer. Gynecol Oncol 108 (1): 100-5, 2008.[PUBMED Abstract]
Rustin GJ, Timmers P, Nelstrop A, et al.: Comparison of CA-125 and standard definitions of progression of ovarian cancer in the intergroup trial of cisplatin and paclitaxel versus cisplatin and cyclophosphamide. J Clin Oncol 24 (1): 45-51, 2006.[PUBMED Abstract]
Green JA, Duffaud F, Coens C, et al.: Prognostic value of clinical and molecular markers in advanced ovarian cancer (AOC): importance of residual (Rs) disease. Translational study using tumor specimens from EORTC 55931/NCIC OV10 Phase III Randomized Clinical Trial (RCT). [Abstract] J Clin Oncol 23 (Suppl 16): A-5005, 456s, 2005.
Bezjak A, Tu D, Bacon M, et al.: Quality of life in ovarian cancer patients: comparison of paclitaxel plus cisplatin, with cyclophosphamide plus cisplatin in a randomized study. J Clin Oncol 22 (22): 4595-603, 2004.[PUBMED Abstract]
Butler L, Bacon M, Carey M, et al.: Determining the relationship between toxicity and quality of life in an ovarian cancer chemotherapy clinical trial. J Clin Oncol 22 (12): 2461-8, 2004.[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
European Organization for Research and Treatment of Cancer
NCIC-Clinical Trials Group
Scottish Gynaecological Cancer Study Group
Lower Bucks Hospital
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.