Trial Information

Phase I Evaluation of Green Tea Extract in Adults With Advanced Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose of green tea extract administered daily
to adults with solid tumors. II. Determine the safety of chronic daily administration of
green tea extract in these patients. III. Investigate the clinical pharmacology of green tea
extract in this study. IV. Document observed antitumor activity of this treatment.

OUTLINE: This is a dose escalation study of green tea extract. Patients receive green tea
extract by mouth daily after meals for 4 weeks. One patient is entered at each dose level.
If grade II toxicities are experienced, then 2 more patients are entered at the same dose
level. One patient must complete 4 weeks of therapy and 2 others must complete 2 weeks of
therapy with no greater than grade I toxicity before dose escalation proceeds. If at least 2
patients experience dose limiting toxicity at any dose level, the immediately preceding dose
level is considered the maximum tolerated dose (MTD). At least 6 patients are studied at the
MTD. Patients may continue therapy for up to 6 months in the absence of toxicity and disease
progression. Patients are followed every 4 weeks for the duration of treatment and at least
one month after completing treatment.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.