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.