A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Capecitabine in Patients With Solid Tumors
- Determine the maximum tolerated dose and recommended phase II dose of vorinostat (SAHA)
and capecitabine in patients with metastatic or unresectable solid tumors.
- Determine the safety and tolerability of this regimen in these patients.
- Correlate the clinical effects with the pharmacokinetic effects of this regimen in
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral vorinostat (SAHA) once or twice daily and oral capecitabine twice
daily on days 1-14. Treatment repeats every 21 days for at least 6 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving a complete response (CR)
receive 2 courses beyond documentation of CR. Patients achieving a partial response receive
2 courses beyond documentation of best response.
Cohorts of 3-6 patients receive escalating doses of SAHA and capecitabine 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. An additional 12 patients are
treated at the MTD.
After completion of study treatment, patients are followed at 3-4 weeks and then every 3
PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study within 6-10
Primary Purpose: Treatment
Maximum tolerated doses of vorinostat (SAHA) and capecitabine
Eric X. Chen, MD, PhD
Princess Margaret Hospital, Canada
United States: Federal Government