Non-Small Cell Lung Cancer Clinical Trial
Official title:
Phase I/II Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer
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.
To evaluate the short term effects of Polyphenon E administered alone and in combination
with erlotinib to patients with advanced Stage IIIB or IV Non Small Cell Lung Cancer (NSCLC)
that has progressed after first line chemotherapy. We will do a Phase I dose escalation
study with Polyphenon E and a fixed dose of erlotinib to evaluate for any significant
adverse events related to the combination.
Once the maximum tolerated dose (MTD) of Polyphenon E has been established the Phase II
trial will be embarked upon using this dose in combination with erlotinib. In both the Phase
I and Phase II parts the agents will administered until time of progression or unacceptable
side effects occur.
The primary end point of the Phase I part is establishing the safety, tolerability and MTD
of Polyphenon E in combination with erlotinib given at 150mg per day.
The Primary endpoint of the Phase II part that will be studied is Response rate (RR) to the
combination. Progression free survival (PFS), Overall Survival (OS) and the safety and
tolerability of Polyphenon E in addition to erlotinib in this subject population and setting
will be assessed as secondary objectives.
Changes in serum markers related to progression of cancer will also be studied as part of
the Phase I and phase II study. The effect of Polyphenon E with or without erlotinib on the
serum levels of circulating c-met RNA, Interleukin-8 (Il-8), Hepatocyte Growth Factor (HGF)
and Vascular Endothelial Growth Factor (VEGF) will be studied as secondary objectives.
Epidermal Growth Factor Receptor (EGFR) expression of the initial tumor tissue and testing
for EGFR mutations in the tumor tissue and serum DNA and evaluation of "KIRSTEN RAT SARCOMA
VIRAL ONCOGENE HOMOLOG" (KRAS) mutations with correlation of these results with treatment
outcome will also be undertaken as secondary objectives in both the Phase I and II parts.
1.1 Determine the safety, tolerability and MTD of Polyphenon E given in combination with
erlotinib. Polyphenon E dose-escalation from 200, 400 and 800mg/day will be performed to
evaluate for the MTD when used together with erlotinib 150mg/d.
1.2 Determine the effects of Polyphenon E in addition to erlotinib on response rate,
progression free survival and overall survival
1.3 Determine the effects of Polyphenon E on circulating serum C-met messenger RNA
1.4 Determine the effects of Polyphenon E on serum HGF levels
1.5 Determine the effects of Polyphenon E on serum Il-8 levels
1.6 Determine the effects of Polyphenon E on serum VEGF levels 1.7 Determine the safety and
tolerability of Polyphenon E in addition to erlotinib in this subject population
1.8 Determine the possible correlation between EGFR expression on original tumor tissue,
EGFR mutations in tumor tissue and serum DNA and the presence of KRAS mutations with the
treatment response and outcome.
This study was intended to be a Phase I/II study. This study never moved into the Phase II
portion of the study. The sponsor stopped supplying Polyphenon E and there was not enough of
a supply in-house to continue with Phase II.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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