A Phase I/II Study of Celecoxib and Erlotinib Hydrochloride as Adjuvant Therapy for High Risk Patients With a History of Hepatocellular Carcinoma
- Determine the safety of adjuvant celecoxib and erlotinib hydrochloride for patients
with hepatocellular carcinoma (HCC) at high risk for recurrence. (phase I)
- Assess disease-free and overall survival of patients treated with adjuvant celecoxib
and erlotinib hydrochloride. (phase II)
- Determine the maximum tolerated dose of celecoxib and erlotinib hydrochloride for the
phase II portion of this trial. (phase I)
OUTLINE: This is a phase I, dose-escalation study followed by an open-label, phase II study.
Patients are assigned to a treatment according to Child-Pugh class of cirrhosis (class
A/noncirrhotic vs class B).
- Phase I: Patients receive oral celecoxib once or twice daily and oral erlotinib
hydrochloride once daily. Treatment continues for up to 6 months in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of celecoxib and erlotinib hydrochloride
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity. Separate dose
escalations are conducted in the 2 groups according to liver dysfunction.
- Phase II: Patients receive celecoxib and erlotinib hydrochloride as in phase I at the
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Safety (phase I)
Alan P. Venook, MD
University of California, San Francisco
United States: Federal Government
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|