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Phase I and pharmacokinetic study of intraperitoneal ormaplatin
S C Plaxe1, P S Braly, J L Freddo
1Division of Gynecologic Oncology, University of California, San Diego 92103-8433.
Gynecologic Oncology
|October 1, 1993
Summary
Intraperitoneal ormaplatin, a cisplatin analog, showed a maximum tolerated dose of 88.4 mg/m2 in a Phase I trial. The recommended dose for future studies is 66.5 mg/m2.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Ormaplatin is a cisplatin analog with preclinical activity against cisplatin-resistant tumors.
- Intraperitoneal chemotherapy offers potential for targeted drug delivery.
Purpose of the Study:
- To evaluate the safety and tolerability of intraperitoneal ormaplatin in a Phase I clinical trial.
- To determine the maximum tolerated dose (MTD) and recommended dose for future studies.
- To characterize the pharmacokinetics of intraperitoneal ormaplatin.
Main Methods:
- Phase I clinical trial involving 14 patients receiving intraperitoneal ormaplatin every 28 days.
- Dose escalation to determine MTD and dose-limiting toxicities.
- Pharmacokinetic analysis of peritoneal fluid and plasma.
Main Results:
- The MTD was determined to be 88.4 mg/m2, with abdominal pain as the dose-limiting toxicity.
- Recommended dose for future trials is 66.5 mg/m2.
- Pharmacokinetic analysis showed a peritoneal elimination half-life of 1.4 hours and a peritoneal-to-plasma AUC ratio of 17.1, suggesting a pharmacologic advantage.
Conclusions:
- Intraperitoneal ormaplatin is feasible with manageable toxicities at the recommended dose of 66.5 mg/m2.
- The drug demonstrated a favorable pharmacokinetic profile with a significant pharmacologic advantage.
- Further investigation is warranted to confirm site-specific activity and clinical benefit.