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Clinical phase I study with one-hour paclitaxel infusion
1Department of Medical Oncology and Clinical Pharmacology, Tumor Biology Center at the Albert-Ludwigs University Freiburg, Germany. mrkl@tumorbio.uni-freiburg.de
Summary
A one-hour infusion of paclitaxel (PAC) at 225 mg/m2 every three weeks is safe and effective for advanced cancers. This schedule showed no significant myelotoxicity and is recommended for further studies.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Paclitaxel (PAC) is a key anti-cancer drug with known schedule-dependent toxicity.
- Previous studies indicated increased toxicity with 24-hour and 3-hour infusions of PAC.
- A phase I study was initiated to evaluate a 1-hour infusion schedule of PAC.
Purpose of the Study:
- To determine the dose-limiting toxicity (DLT) of a 1-hour paclitaxel infusion.
- To establish the maximum tolerated dose (MTD) for this infusion schedule.
- To assess the anti-cancer efficacy of the 1-hour paclitaxel infusion.
Main Methods:
- Patients with advanced malignant tumors received 1-hour infusional paclitaxel.
- Dosing started at 150 mg/m2 and escalated in 25 mg/m2 increments.
- Therapy was repeated every three weeks until disease progression; efficacy was assessed after at least two cycles.
Main Results:
- The maximum tolerated dose (MTD) was determined to be 250 mg/m2.
- The dose-limiting toxicity (DLT) was identified as grade 3 central and peripheral neuropathy.
- Partial response was observed in 24% of evaluable patients; no significant myelotoxicity was noted.
Conclusions:
- A 1-hour infusion of paclitaxel at 225 mg/m2 every three weeks is safe.
- This schedule demonstrates no significant myelotoxicity.
- The 225 mg/m2 dose is recommended for phase II studies.