MedTrace Logo

Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer

NCT00707252 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-04-21

No results posted yet for this study

Summary

The purpose of this study is to study if the addition of the green tea extract, Polyphenon E, to Erlotinib is safe and if it has potential to improve outcomes in second line therapy for Advanced Stage IIIb/IV Non-small cell lung cancer.

Conditions

Interventions

DRUG

Polyphenon E

Patients will be assigned to 3 sequential cohorts of three different dose levels of Polyphenon E (providing 200, 400 and 800mg of Polyphenon E given once daily) in a step-wise manner.

DRUG

Tarceva

All patients will also receive Erlotinib 150mg po/day from Day 1.

Sponsors & Collaborators

  • Polyphenon E International,Inc.

    collaborator INDUSTRY

  • Louisiana State University Health Sciences Center Shreveport

    lead OTHER

Principal Investigators

  • Glenn M Mills, MD · LSU Health Sciences Center - Shreveport

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707252 on ClinicalTrials.gov