Bladder Cancer Clinical Trial
Official title:
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
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.
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