- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Contact
- Name: Xindong Sun, M.D.
- Phone Number: 0086-053167626141
- Email: zhx7152028@yahoo.com.cn
Study Contact Backup
- Name: Hanxi Zhao, M.D.
- Phone Number: 0086-053167626142
- Email: 171459576@qq.com
Study Locations
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Shandong
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Jinan, Shandong, China, 250117
- Available
- Shan Dong cancer hospital and institute
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Contact:
- Xindong Sun, M.D.
- Phone Number: 0086053167626141
- Email: zhx87520052@163.com.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Study Director: Xindong Sun, M.D., Shan Dong Tumor Hospital and Institute
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Neuroprotective Agents
- Protective Agents
- Antioxidants
- Anticarcinogenic Agents
- Antimutagenic Agents
- Epigallocatechin gallate
Other Study ID Numbers
- GTESCLC2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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