Phase I: Polyphenon E + Erlotinib - Polyphenon E 200, 400 and 800 mg/day dose levels evaluated in a step-wise manner with Erlotinib 150 mg/day to establish Maximum Tolerated Dose (MTD) of Polyphenon E. Phase II consists of MTD of Polyphenon E established in Phase I, administered alone for two weeks and thereafter together with Erlotinib 150 mg/day.

Non-Small Cell Lung Cancer

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.

Polyphenon E

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

Tarceva

LSUHSC-Shreveport, Feist-Weiller Cancer Center

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

Phase I/II Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer

Toxicity evaluation of all adverse events monitored by physical exam, weight, vital signs, Complete Blood Count (CBC), Complete Metabolic Panel (CMP), coagulation panel and Computed Tomography (CT) scans of the chest, abdomen and pelvis, CT/Magnetic Resonance Imaging (MRI) of the head.

Dose-Limiting Toxicity (DLT) is defined as two or more events with grade 3 toxicity or a single event with grade 4-5 toxicity possibly or probably related to the study medications at a specific dose of Polyphenon E.

Response Rate defined as Complete (CR) + Partial Response (PR) using RECIST criteria.
Complete response (CR):
Complete disappearance of all measurable and non-measurable disease, no new lesions, no disease related symptoms, and normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline.
Partial Response (PR):
Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.

Progression- Free Survival:
From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.

From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.

Time from registration to death of any cause measured in months.

To analyze signaling pathway activity western blot analysis will be performed using antibodies that recognize serum interleukin-8 (IL-8), VEGF and HGF levels. The level of circulating C-met RNA will be measured using Real Time Polymerase Chain Reaction (RT-PCR).

camellia murauchii/sarcoma

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

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