NCT00088946

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polyphenon E	4-200mg capsules PO daily for 12 months
DRUG	erlotinib hydrochloride	100 mg PO daily for 12 months
OTHER	Erlotinib placebo	identical to Erlotinib in look and appearance of dosing.
OTHER	Polyphenon E	identical to Polyphenon E in look and appearance of dosing.

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2004-08-05
• Last updated: 2020-07-31

Locations

5 sites across 1 country: United States