Experiment 67701
Worktypes
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | ORAL |
| Organism | Camellia sinensis (THEACEAE) |
| Citation | PISTERS,KMW: NEWMAN,RA: COLDMAN,B: SHIN,DM: KHURI,FR: HONG,WK: GLISSON,BS: LEE,JS:. (2001). PHASE I TRIAL OF ORAL GREEN TEA EXTRACT IN ADULT PATIENTS WITH SOLID TUMORS.. 19(6) |
| Amount utilized | |
| Compound isolated | |
| Disease | THIS TRIAL WAS DESIGNED TO DETERMINE THE MAXIMUM-TOLERATED DOSE, TOXICITY, AND PHARMACOLOGY OF ORAL GREEN TEA EXTRACT (GTE) ONCE DAILY OR THREE TIMES DAILY. COHORTS OF THREE OR MORE ADULT CANCER PATIENTS WERE ADMINISTERED ORAL GTE WITH WATER AFTER MEALS ONE OR THREE TIMES DAILY FOR 4 WEEKS, TO A MAXIMUM OF 6 MONTHS, DEPENDING ON DISEASE RESPONSE AND PATIENT TOLERANCE. PHARMACOKINETIC ANALYSES WERE ENCOURAGED BUT OPTIONAL. DOSE LEVELS OF 0.5 TO 5.05 G/M2 QD AND 1.0 TO 2.2 G/M2 TID WERE EXPLORED. A TOTAL OF 49 PATIENTS WERE STUDIED. MILD TO MODERATE TOXICITIES WERE SEEN AT MOST DOSE LEVELS AND PROMPTLY REVERSED ON DISCONTINUATION OF GTE. DOSE-LIMITING TOXICITIES WERE CAFFEINE RELATED AND INCLUDED NEUROLOGIC AND GASTROINTESTINAL EFFECTS. THE MAXIMUM-TOLERATED DOSE WAS 4.2 G/M2 ONCE DAILY OR 1.0 G/M2 THREE TIMES DAILY. NO MAJOR RESPONSES OCCURRED. |
| Dose amount | VAR |
| Number | 3 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Dose expression | DOSE |
| Extract | H2O EXT |
| Gender | GIVEN TO BOTH SEXES |