Clinical trials with intraperitoneal cisplatin microspheres for malignant ascites--a pilot study

Area of Science:

• Oncology
• Drug Delivery Systems
• Gastroenterology

Background:

• Peritoneal carcinomatosis frequently causes malignant ascites.
• Effective local treatment options for malignant ascites are limited.
• Cisplatin is a chemotherapy agent with potential for ascites management.

Purpose of the Study:

• To evaluate the clinical efficacy and safety of a new cisplatin formulation (CDDP-MS) for treating malignant ascites.
• To assess the pharmacokinetic profile of cisplatin delivered via microspheres.
• To determine the response rate and tolerability of CDDP-MS in patients with digestive organ cancers.

Main Methods:

• A pilot study involving thirteen patients with malignant ascites.
• Intraperitoneal administration of CDDP-MS (cisplatin-loaded lactic acid oligomer microspheres).
• Dosage: 100 mg or 200 mg cisplatin per person.
• Monitoring of total platinum levels in ascites and blood plasma.
• Assessment of ascites reduction and side effects.

Main Results:

• Complete resolution of malignant ascites in 8 patients (62%) and partial response in 4 patients (31%), yielding a 92% overall response rate.
• Sustained high platinum concentrations in ascites for one week post-administration.
• Low platinum concentrations observed in blood plasma, indicating limited systemic exposure.
• The formulation was generally well-tolerated with minimal side effects.

Conclusions:

• Intraperitoneal CDDP-MS demonstrates significant therapeutic benefit for malignant ascites.
• The microsphere formulation allows for sustained local drug delivery and reduced systemic toxicity.
• CDDP-MS represents a promising treatment option for malignant ascites in patients with digestive organ cancers.