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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT01317953
Other study ID # GTESCLC2011
Secondary ID
Status Available
Phase
First received
Last updated

Study information

Verified date April 2019
Source Shandong Cancer Hospital and Institute
Contact Xindong Sun, M.D.
Phone 0086-053167626141
Email zhx7152028@yahoo.com.cn
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
epigallocatechin gallate
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),

Locations

Country Name City State
China Shan Dong cancer hospital and institute Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

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