NCT01317953

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
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),

Timeline

• First posted: 2011-03-18
• Last updated: 2019-04-05

Locations

1 site across 1 country: China