Erlotinib and Green Tea Extract (Polyphenon® E) in Preventing Cancer Recurrence in Former Smokers Who Have Undergone Surgery for Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00088946|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : October 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Dietary Supplement: Polyphenon E Drug: erlotinib hydrochloride Other: Erlotinib placebo Other: Polyphenon E||Phase 2|
- 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 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 (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
U.S. FDA Resources
Experimental: Arm 1
Polyphenon E plus erlotinib placebo daily for 12 months.
Dietary Supplement: Polyphenon E
4-200mg capsules PO daily for 12 months
Other Name: green tea extractOther: Erlotinib placebo
identical to Erlotinib in look and appearance of dosing.
Experimental: Arm 2
Erlotinib and Polyphenon E placebo daily for 12 months.
Drug: erlotinib hydrochloride
100 mg PO daily for 12 months
Other Name: TarcevaOther: Polyphenon E
identical to Polyphenon E in look and appearance of dosing.
Placebo Comparator: Arm 3
Erlotinib placebo and Polyphenon E placebo 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088946
|United States, Arizona|
|Bladder Cancer Genitourinary Oncology, PC|
|Phoenix, Arizona, United States, 85032|
|United States, California|
|Veterans Affairs Medical Center - West Los Angeles|
|Los Angeles, California, United States, 90073|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Santa Monica UCLA Medical Center|
|Santa Monica, California, United States, 90404|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Arie Belldegrun, MD, FACS||Jonsson Comprehensive Cancer Center|