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Gemcitabine and UFT plus oral calcium folinate: phase I study
P A Philip1, D Ibrahim, M Zalupski
1Division of Hematology and Oncology, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.
Oncology (Williston Park, N.Y.)
|August 12, 1999
Summary
This Phase I study explores combining gemcitabine with UFT and calcium folinate for solid tumors. Myelosuppression was the primary toxicity observed in early trials.
Area of Science:
- Oncology
- Pharmacology
- Cancer Therapeutics
Background:
- Gemcitabine is a nucleoside analog used to treat various solid tumors by inhibiting DNA synthesis.
- Potential synergistic effects exist between gemcitabine and other antimetabolites like 5-fluorouracil.
- Gemcitabine and UFT (uracil and tegafur) plus oral calcium folinate (Orzel) have distinct dose-limiting toxicities, suggesting combination therapy potential.
Purpose of the Study:
- To determine the maximum tolerated doses (MTDs) of gemcitabine in combination with UFT plus oral calcium folinate.
- To evaluate the safety and tolerability of this combination regimen in patients with solid tumors.
Main Methods:
- Phase I clinical trial design.
- Dose escalation study to identify MTDs.
- Recruitment of patients with various solid tumors.
Main Results:
- Eight patients were recruited in the study to date.
- Myelosuppression was identified as the principal dose-limiting toxicity.
- Further data collection is ongoing to fully characterize safety and tolerability.
Conclusions:
- The combination of gemcitabine, UFT, and calcium folinate is under investigation for solid tumor treatment.
- Myelosuppression is a key toxicity to monitor in this combination therapy.
- Additional research is needed to establish optimal dosing and efficacy.