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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
17
4-200mg capsules PO daily for 12 months
100 mg PO daily for 12 months
identical to Erlotinib in look and appearance of dosing.
identical to Polyphenon E in look and appearance of dosing.
Bladder Cancer Genitourinary Oncology, PC
Phoenix, Arizona, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Santa Monica UCLA Medical Center
Santa Monica, California, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Evaluate the effects of a daily oral dose of polyphenon E, erlotinib, or placebo on subjects who are former smokers with a history of superficial bladder cancer on the bladder cancer recurrence rate at two years of any stage or grade of bladder cancer.
Time frame: 2 years
To address the unmet need in medical management of superficial bladder cancer as an adjunct to standard of care.
Time frame: 2 years
Assess toxicities associated with daily oral dosing of polyphenon E or erlotinib in subjects at risk for bladder tumor recurrence and to define a safe and effective prevention dose of erlotinib.
Time frame: 2 years
Correlate the modulation of one or more biomarkers with recurrence of bladder cancer confirming the value as a surrogate endpoint biomarker for bladder cancer recurrence and/or progression.
Time frame: 2 years
To assess the risk of clinical bladder cancer progression in patients treated with polyphenon E, erlotinib or placebo.
Time frame: 2 years
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