Phase I dose-escalation and pharmacokinetic study of temozolomide (SCH 52365) for refractory or relapsing malignancies
1999
Study of Temozolomide for Hard-to-Treat Cancers
Sample size: 30
publication
Evidence: moderate
Author Information
Author(s): Brada M, Judson I, Beale P, Moore S, Reidenberg P, Statkevich P, Dugan M, Batra V, Cutler D
Primary Institution: The Royal Marsden NHS Trust and the Institute of Cancer Research
Hypothesis
What is the safety and effectiveness of temozolomide in patients with refractory or relapsing malignancies?
Conclusion
Temozolomide is well tolerated and shows clinical activity against several advanced cancers.
Supporting Evidence
- Temozolomide showed clinical activity against malignant glioma and metastatic melanoma.
- The maximum tolerated dose was determined to be 200 mg m−2 per day.
- Food slightly reduced the absorption of temozolomide by 9%.
- The drug was well tolerated with mild to moderate nausea and vomiting.
Takeaway
This study tested a cancer drug called temozolomide on 30 patients, and it worked well without causing too many side effects.
Methodology
Temozolomide was given to patients in escalating doses to determine safety and pharmacokinetics.
Participant Demographics
Patients had minimal prior chemotherapy.
Digital Object Identifier (DOI)
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