A Randomized Phase II Study of Two Dose-Levels of Vorinostat in Combination With 5-FU and Leucovorin in Patients With Refractory Metastatic Colorectal Cancer
PRIMARY OBJECTIVES: I. Describe the 2-months progression free rate on vorinostat 800mg/day x
3 in combination with 5-FU/L V every 2 weeks. (Arm I) II. Describe the 2-months progression
free rate on vorinostat 1400mg/day x 3 in combination with 5-FU/L V every 2 weeks. (Arm II)
SECONDARY OBJECTIVES: I. Describe the response rate on Arm 1 and Arm 2 of the study. II.
Estimate the median progression free survival on both arms of the study. III. Describe the
overall survival on Arm 1 and Arm 2 of the study. IV. Describe the toxicities on Arm 1 and
Arm 2 of the study. V. Describe vorinostat pharmacokinetics on Arm 1 and Arm 2 of the study.
VI. Describe 5-FU steady state pharmacokinetics on Arm 1 and Arm 2 of the study. OUTLINE:
Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive low-dose oral
vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and
fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence
of disease progression or unacceptable toxicity. ARM II: Patients receive high-dose oral
vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I.
Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up for 30 days and then every 3
months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease control rate (stable disease or objective response)
At 2 months
No
Wen Wee MA, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 142808
NCT00942266
July 2009
December 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |