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Weekly gemcitabine in advanced or metastatic solid tumors. A clinical phase I study
C F Pollera1, A Ceribelli, M Crecco
1Division of Medical Oncology, Istituto Regina Elena per lo Studio e la Cura dei Tumori, Rome, Italy.
Investigational New Drugs
|January 1, 1994
Summary
This Phase I trial determined the maximum tolerated dose (MTD) for gemcitabine (GEM), a novel chemotherapy, in advanced solid tumors. The MTD was established at 1,370 mg/m2/wk, with dose-limiting leucopenia and non-hematologic toxicities observed.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Gemcitabine (GEM) is a deoxycytidine analogue with demonstrated antitumor activity.
- Preliminary studies indicated schedule-dependent maximum tolerated doses (MTDs) for GEM.
Purpose of the Study:
- To evaluate escalating doses of weekly gemcitabine (GEM) administered via a 30-minute infusion.
- To determine the MTD and characterize toxicity profiles of GEM in patients with advanced solid tumors.
Main Methods:
- A Phase I clinical trial involving dose escalation of weekly GEM.
- 39 patients with advanced solid tumors received treatment across six dose-level steps.
- The MTD was defined based on dose-limiting toxicities.
Main Results:
- The MTD for weekly GEM was determined to be 1,370 mg/m2/wk.
- Dose-limiting leucopenia and increased non-hematologic toxicities were observed at the MTD.
- Common toxicities included leucopenia (44%), fever (69%), and emesis (38%).
Conclusions:
- Weekly gemcitabine can be escalated to 1,370 mg/m2/wk.
- Leucopenia is the dose-limiting toxicity, with significant non-hematologic toxicities also noted at the MTD.
- Further investigation into GEM's efficacy at the MTD is warranted.