Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
18 Years
70 Years
Both
Small Cell Lung Carcinoma
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity as measured by CTCAE
Outcome Description:
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.
Outcome Time Frame:
4 weeks
Safety Issue:
Yes
Principal Investigator
Xindong Sun, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Shan Dong Tumor Hospital and Institute
Authority:
China: Food and Drug Administration
Study ID:
GTESCLC2011
NCT ID:
NCT01317953
Start Date:
May 2011
Completion Date:
May 2012
Related Keywords:
- Small Cell Lung Carcinoma
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
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