A Pilot Study of Flavopiridol in Patients With Advanced Solid Tumors
I. Determine the toxicity profile and dose-limiting toxicity of flavopiridol (alvocidib) in
patients with locally advanced or metastatic solid tumors.
II. Determine the maximum tolerated dose of this drug in these patients.
I. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
II. Determine the immunomodulatory effects of this drug in these patients. III. Determine
pharmacogenomics of this drug, using peripheral blood mononuclear cells, in patients who
experience clinical response.
OUTLINE: This is a pilot, dose-escalation study.
Patients receive alvocidib intravenously (IV) over 4½ hours once weekly in weeks 1-4.
Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving stable disease after 4 courses of therapy
discontinue study treatment. Patients who achieve complete remission (CR) receive 1
additional course of therapy beyond documentation of CR. Cohorts of 3-6 patients receive
escalating doses of alvocidib until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. A total of 10 patients are treated at the MTD.
After completion of study treatment, patients are followed within 4 weeks.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adverse events of dose escalated alvocidib administered in patients with advanced solid tumors
Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
At weeks 1-4, 7-10, 11 or 12, and within 4 weeks after the completion of study treatment
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|