Phase II trial of intraperitoneal cisplatin combined with intravenous paclitaxel in patients with ovarian, primary peritoneal and fallopian tube cancer

Background.The objective of this study was to determine the toxicity of cisplatin-based intraperitoneal (IP)/intravenous (IV) treatment using a modified version of the IP/IV arm of GOG 172.Methods.Patients with stage IC-IV and recurrent ovarian cancer were treated with D1 paclitaxel (IV at 135 mg/m², 3-h infusion) and cisplatin (IP at 50 mg/m²) and D8 cisplatin (IP at 50 mg/m²) every 21 days for 6 cycles. The primary outcome measure was completion of 6 cycles. Toxicity was assessed using the CTCAE, v.3.0 as well as subjective reporting by patients after each cycle.Results.Twenty-one patients completed 87 cycles of chemotherapy with IP cisplatin and intravenous (IV) paclitaxel. Eleven patients (52%) were able to complete all 6 cycles. Reasons for failing to complete treatment: progression of disease (n = 3), grade 3–4 ototoxicity (n = 2), IP port complication (n = 1), grade 4 fatigue (n = 1), small bowel obstruction (n = 1), severe paclitaxel reaction (n = 1) and one patient refused further treatment (n = 1). Dose reductions of paclitaxel (135 mg/m² to 110 mg/m²) were implemented per protocol for neutropenia (n = 3) at a frequency of 3.75%. Dose delays were noted prior to 9 cycles for neutropenia (n = 6), thrombocytopenia (n = 1), elevated creatinine (n = 1), and grade 3 rash (n = 1) at a frequency of 10%.Conclusions.Although only 52% of patients were able to complete 6 cycles of cisplatin-based IP chemotherapy, significant reductions in cisplatin-related metabolic toxicity and catheter-related complications were noted.

Research highlights
► Cisplatin-based IP chemotherapy is well tolerated in an ambulatory setting with dosing and schedule modifications as well as aggressive pre-treatment.
► Completion rates of IP chemotherapy were less than predicted but improved over completion rates from GOG 172.