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
- 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.
- 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
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
In all arms, treatment continues for 12 months in the absence of disease recurrence or
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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.
Arie Belldegrun, MD, FACS
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Veterans Affairs Medical Center - West Los Angeles||Los Angeles, California 90073|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Bladder Cancer Genitourinary Oncology, PC||Phoenix, Arizona 85032|
|Santa Monica UCLA Medical Center||Santa Monica, California 90404|