Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer.

摘要: Objective: To evaluate the safety and efficacy of canfosfamide in combination with pegylated liposomal doxorubicin (PLD) platinum-resistant ovarian cancer (OC). Methods: Patients platinum-refractory or -resistant (primary secondary) OC were randomized to receive at 1000 mg/m2 PLD 50 intravenously alone on day 1 every 28 days until tumor progression unacceptable toxicity. The primary end point was progression-free survival (PFS). Other points objective response rate safety. study originally planned for 244 patients. trial temporarily placed hold after 125 patients while results another being reviewed sponsor decided not resume enrollment. interim analysis became final analysis. Results: median PFS 5.6 months + (n = 65) versus 3.7 60) (hazards ratio, 0.92; P 0.7243). A preplanned subgroup showed that 75 had a 2.9 0.55; 0.0425). Hematologic adverse events 66% arm 44% arm, manageable dose reductions. Nonhematologic similar both arms. incidence palmar-plantar erythrodysesthesia stomatitis lower (23%, 31%, respectively) (39%, 49%, PLD. Conclusions: Overall positive trend but statistically significant. significantly longer Canfosfamide may ameliorate known be associated Further this active well-tolerated regimen is planned. This registered www.clinicaltrials.gov: NCT00350948.