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Transitional Cell Carcinoma

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Erlotinib Hydrochloride

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Tyrosine

Polyphenon E plus erlotinib placebo daily for 12 months.

Erlotinib and Polyphenon E placebo daily for 12 months.

Erlotinib placebo and Polyphenon E placebo daily for 12 months.

Polyphenon E

erlotinib hydrochloride

identical to Erlotinib in look and appearance of dosing.

Erlotinib placebo

identical to Polyphenon E in look and appearance of dosing.

Arie Belldegrun, MD, FACS

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Green tea extract (Polyphenon® E) contains certain ingredients that may slow the growth of tumor cells and prevent the recurrence of cancer. Giving erlotinib or green tea extract after surgery may kill any remaining tumor cells and may prevent the recurrence of bladder cancer.

PURPOSE: This randomized phase II trial is studying how well giving erlotinib together with green tea extract works in preventing cancer recurrence in former smokers who have undergone surgery for bladder cancer.

OBJECTIVES:

Primary

* Compare the effects of erlotinib vs green tea extract (Polyphenon® E) vs placebo on the 2-year recurrence rate in former smokers with resected superficial transitional cell carcinoma of the bladder.
* Develop an effective chemopreventative strategy (as an adjunct to standard care) for the medical management of superficial bladder cancer in these patients.

Secondary

* Determine the toxic effects associated with these drugs in these patients.
* Determine a safe and effective chemopreventative dose of erlotinib in these patients.
* Correlate the modulation of 1 or more biomarkers with bladder cancer recurrence and/or progression in patients treated with these drugs.
* Determine the risk of clinical bladder cancer progression in patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (Ta vs T1 vs carcinoma in situ) and participating center. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive oral erlotinib and oral green tea extract (Polyphenon® E) placebo once daily.
* Arm II: Patients receive oral green tea extract (Polyphenon® E) and oral erlotinib placebo once daily.
* Arm III: Patients receive oral erlotinib placebo and oral green tea extract placebo once daily.

In all arms, treatment continues for 12 months in the absence of disease recurrence or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 330 patients (110 per treatment arm) will be accrued for this study within 3 years.

Erlotinib and Green Tea Extract (Polyphenon® E) in Preventing Cancer Recurrence in Former Smokers Who Have Undergone Surgery for Bladder Cancer

Parallel, Randomized, Double-Blind, Placebo Controlled Phase II Adjuvant Studies of Erlotinib and Polyphenon E to Prevent the Recurrence and Progression of Tobacco-Related, Superficial Bladder Cancer

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Erlotinib and Green Tea Extract (Polyphenon® E) in Preventing Cancer Recurrence in Former Smokers Who Have Undergone Surgery for Bladder Cancer	NCT00088946	Bladder Cancer	Polyphenon E erlotinib hydro... Erlotinib place... Polyphenon E	18 Years -	Jonsson Comprehensive Cancer Center
Erlotinib and Green Tea Extract (Polyphenon® E) in Preventing Cancer Recurrence in Former Smokers Who Have Undergone Surgery for Bladder Cancer	NCT00088946	Bladder Cancer	Polyphenon E erlotinib hydro... Erlotinib place... Polyphenon E	18 Years -	Jonsson Comprehensive Cancer Center

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