Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin and Paclitaxel in Patients With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study

Purpose: In randomized trials the combination of cispla- tin and paclitaxel was superior to cisplatin and cyclophos- phamide in advanced-stage epithelial ovarian cancer. Al- though in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population. Patients and Methods: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin area under the curve 7.5 intrave- nously plus paclitaxel 175 mg/m2 over 3 hours (arm II). Results: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression- free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02). Conclusion: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus pacli- taxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.

Journal Ref. Ozols, RF et al. (2003). Journal of Clinical Oncology, 21:3194-3200
Intervention Drug - Carboplatin (AUC 7.5mg/mL/min) + paclitaxel (175mg/m3) as a 3-hour infusion
Number of sites 1
Countries involved United States
Sample size 840
Type of statistical analyses Intention to Treat
Risk of bias Overall: High Risk details
Participant characteristics Age: Median (overall): 51-60 years
Condition: GOG Performance Status: 0 - 2
Baseline severity: Tumor Grade 3: Intervention = 54%, Control = 55%
Duration of trial 5 Years
Primary outcome Progression-Free Survival and Overall Survival
Show Score Ranges


(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
1 1 2 1 3 1 1 4 5