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Oral Green Tea Extract for Small Cell Lung Cancer
Conditions
Small Cell Lung Carcinoma
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: epigallocatechin gallate
Type: Dietary Supplement
Overall Status
Recruiting
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.
Detailed Description
Small-cell lung cancer accounts for 13 to 15% of all lung cancer and more than 60 to 70% of patients present with extensive disease (ED). Although etoposide plus cisplatin (EP) regimen has been the mainstay of ED-SCLC treatment, median overall survival is about 9 months, with 5 to 10% surviving two years and only 1% of patients achieving a long-term disease-free survival. To improve this outcome further, various attempts have been made, which included dose intensification with stem cell supports, maintenance therapy, and also searches for a better chemotherapy regimen.
Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.
Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Location
Shan Dong cancer hospital and institute
Jinan, Shandong, China
Status: Recruiting
Contact: Xindong Sun, M.D. - 0086053167626141 - zhx87520052@163.com.cn
Start Date
May 2011
Completion Date
August 2020
Sponsors
Shandong Cancer Hospital and Institute
Source
Shandong Cancer Hospital and Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page