Phase I Study of Lobaplatin
Author Information
Author(s): J.A. Gietema, E.G.E. de Vries, D. Th. Sleijfer, P.H.B. Willems, H.-J. Guchelaar, D.R.A. Uges, P. Aulenbacher, R. Voegeli, N.H. Mulder
Primary Institution: University Hospital Groningen, The Netherlands
Hypothesis
What is the maximum tolerated dose of lobaplatin administered daily for 5 days?
Conclusion
Lobaplatin is well tolerated with predictable dose-related side effects, and its maximum tolerated dose varies based on renal function.
Supporting Evidence
- Thrombocytopenia was the dose-limiting toxicity observed in the study.
- The maximum tolerated dose was found to be related to renal function.
- 91.5% of the platinum dose was excreted within 4 hours.
- Two patients with ovarian cancer showed a partial and complete response.
- Statistical analysis showed a significant correlation between observed and predicted platelet nadir.
- Patients pretreated with platinum compounds experienced more nausea.
- No renal function impairment occurred during the study.
- The study provided evidence that lobaplatin might be non-cross resistant with cisplatin.
Takeaway
This study tested a new cancer drug called lobaplatin to see how much can be safely given to patients. It found that the safe dose depends on how well the patients' kidneys work.
Methodology
Patients received lobaplatin as an intravenous bolus daily for 5 days, with dose adjustments based on renal function.
Limitations
The study had a small sample size and was limited to patients with advanced cancers not amenable to conventional treatment.
Participant Demographics
Patients aged 18 to 75 with advanced cancers, including 11 males and 16 females.
Statistical Information
P-Value
p<0.001
Statistical Significance
p<0.001
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