Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity as measured by CTCAE
Patients receive oral green tea extract twice daily for 4 weeks and be followed closely with physical exams, hematological and biochemical testing. Dose-limiting toxicity was measured by CTCAE. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or un-acceptable toxicity. Cohorts of 3-6 patients receive escalating doses of green tea extract until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Xindong Sun, M.D.
Shan Dong Tumor Hospital and Institute
China: Food and Drug Administration