Oral Green Tea Extract for Small Cell Lung Cancer
Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedApril 5, 2019
April 1, 2019
March 17, 2011
April 3, 2019
Conditions
Interventions
Starting dose green tea catechin extract "EGCG" 400 mg twice a day (BID) of EGCG (400 mg caps BID), second escalated dose 800 mg BID of EGCG (2x400 mg caps BID), third escalated dose 1200 mg BID of EGCG (3x400 mg),fourth escalated dose 1600 mg BID of EGCG (4x400 mg),and fifth escalated dose 2000 mg BID of EGCG (5x400 mg),
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of small cell lung cancer
- extensive-stage disease
- Eastern Cooperative Oncology Group performance status (PS) of 0 to 2
- age18 years old
- Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl
- Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
- Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
- Signed written informed consent prior to study entry
- According to Response Evaluation Criteria in Solid Tumors(RECIST), patients didn't progress after first-line chemotherapy
You may not qualify if:
- Any condition that would hamper informed consent or ability to comply with the study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than SCLC
- Recent consumption of green tea (5 or more cups per day within one week of study enrollment)
- Pregnant and lactating women
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to EGCG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shan Dong cancer hospital and institute
Jinan, Shandong, 250117, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xindong Sun, M.D.
Shan Dong Tumor Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
March 17, 2011
First Posted
March 18, 2011
Last Updated
April 5, 2019
Record last verified: 2019-04