Oral Green Tea Extract for Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Shandong Cancer Hospital and Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01317953
First received: March 17, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Carcinoma
Dietary Supplement: epigallocatechin gallate
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase ⅠStudy of Oral Green Tea Extract as Maintenance Therapy for Extensive-stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Dose-limiting toxicity as measured by CTCAE [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • progression free survival [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Determine the effects of EGCG on serum markers: neuron specific enolase (NSE), carcinoma embryonic antigen (CEA) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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),
    Other Names:
    • epigallocatechin gallate
    • EGCG
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317953

Contacts
Contact: Xindong Sun, M.D. 0086-053167626141 zhx7152028@yahoo.com.cn
Contact: Hanxi Zhao, M.D. 0086-053167626142 171459576@qq.com

Locations
China, Shan Dong
Shan Dong cancer hospital and institute Recruiting
Jinan, Shan Dong, China, 250117
Contact: Xindong Sun, M.D.    0086053167626141    zhx7152028@yahoo.com.cn   
Contact: Hanxi Zhao, M.D.    0086053167626142    171459576@qq.com   
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Study Director: Xindong Sun, M.D. Shan Dong Tumor Hospital and Institute
  More Information

No publications provided

Responsible Party: Han Xi Zhao, M.D., Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01317953     History of Changes
Other Study ID Numbers: GTESCLC2011
Study First Received: March 17, 2011
Last Updated: November 28, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Epigallocatechin gallate
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014