A Phase Ii Study Of The Feasibility Of Sequential Carboplatin (C) Followed By Paclitaxel (P) And Gemcitabine (G) As First-Line Chemotherapy For Stage Ic-Iv Ovarian (Oc), Fallopian Tube (Ftc), And Primary Peritoneal Carcinoma (Ppc)

5578 Background: We previously explored the feasibility of adding G to C + P in a phase II study, in which 4 cycles of C followed by 4 cycles of concurrent weekly P and G were given (BJC (2004) 91:627–32). Although highly active (med PFS 19.5m), the feasibility of this 1st-line regimen was limited by dyspnea during the weekly P+G phase. The current trial assessed whether the dyspnoea could be ameliorated by altering the schedule. Methods: Untreated FIGO stage Ic-IV OC, FTC and PPC patients (pts) were eligible. Chemotherapy (CTX) consisted of 4 cycles of C (AUC 7) q21 days, followed by 4 cycles of concurrent P (175 mg/m2) d1 and G (1,000 mg/m2) d1 and d8 q21 days. The primary endpoint of the study was the percentage of pts completing the planned 8 cycles of CTX. The planned sample size was 54 pts, based on a one stage single arm study design with 95% power to reject the null hypothesis (completion rate less than 60%), assuming a true completion rate of 80% using one-sided alpha=0.05. Results: All 54 pts we...