Green Tea Extract in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003197
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers, as well as prevent the development of new cancers.

PURPOSE: Phase I trial to study the effectiveness of green tea extract in treating patients with advanced solid tumors that are refractory to standard therapy.

Detailed Description

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.

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-06
• Study Completion: 2000-06
• Study First Submitted QC: 2004-08-11
• Study First Posted: 2004-08-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States