Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-cell Neoplasms
I. To determine the recommended phase II dose of bortezomib and flavopiridol in patients
with recurrent or refractory indolent B-cell neoplasms.
I. To determine the toxic effects and maximum tolerated dose of this regimen in these
II. To determine disease-related effects of this regimen in these patients. III. To
determine the pharmacodynamics of this regimen in patients with myeloma.
IV. To determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on
days 1, 4, 8, and 11.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Virginia Commonwealth University||Richmond, Virginia|