Green Tea Extract in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003197
Recruitment Status : Completed
First Posted : August 12, 2004
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: green tea extract Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: Phase I Evaluation of Green Tea Extract in Adults With Advanced Solid Tumors
Study Start Date : December 1997
Actual Primary Completion Date : June 2000
Actual Study Completion Date : June 2000

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Pathologically proven incurable advanced solid tumor refractory to standard therapy or for which no standard therapy exists No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 1.25 times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease Other: No significant metabolic disorder No significant infection Not pregnant or nursing Effective contraception must be used by fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks (6 weeks for nitrosourea) since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003197

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Vincent A. Miller, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00003197     History of Changes
Other Study ID Numbers: 97-128
CDR0000066033 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 12, 2004    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific