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Gemcitabine, Paclitaxel, and piritrexim: a phase I study
Glenn Liu1, Howard H Bailey, Rhoda Z Arzoomanian
1University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, USA.
American Journal of Clinical Oncology
|June 11, 2003
Summary
This Phase I trial evaluated a combination of piritrexim, paclitaxel, and gemcitabine in cancer patients. The drug combination demonstrated safety and tolerability, warranting further investigation in Phase II trials.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Piritrexim is an antifolate effective in methotrexate-resistant tumors.
- Gemcitabine, a nucleoside analog, shows activity in various cancers and synergizes with antifolates.
- Paclitaxel is an antimicrotubule agent with broad-spectrum activity in solid tumors.
Purpose of the Study:
- To assess the safety and tolerability of a combination therapy.
- To determine the maximum tolerated dose (MTD) of the piritrexim, paclitaxel, and gemcitabine regimen.
- To explore preliminary efficacy of the combination in cancer patients.
Main Methods:
- Phase I clinical trial design.
- Dose escalation study enrolling 30 patients.
- Combination regimen: piritrexim, paclitaxel, and gemcitabine administered on a defined schedule.
Main Results:
- Myelosuppression was the primary dose-limiting toxicity.
- The maximum tolerated dose was identified.
- Four patients achieved stable disease; one partial response was observed in a neuroendocrine tumor.
Conclusions:
- The combination of piritrexim, paclitaxel, and gemcitabine appears safe and tolerable.
- Further Phase II trials are recommended for tumors known to respond to these agents, such as transitional cell carcinomas.