Stage III Bladder Cancer Clinical Trial
Official title:
A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG
Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.
PRIMARY OBJECTIVES I. To compare the levels of epigallocatechin-3-gallate (EGCG) in
nonmalignant bladder tissue from patients with bladder cancer treated with oral polyphenon E
800 mg EGCG or polyphenon E 1200 mg EGCG once daily for 14-28 days.
SECONDARY OBJECTIVES:
I. To compare the levels of EGCG in nonmalignant versus malignant bladder tissue samples from
these patients.
II. To examine the dose-response modulation of surrogate intermediate endpoint biomarkers
(e.g., Proliferating Cell Nuclear Antigen [PCNA], Matrix Metallopeptidase 2 [MMP2],
clusterin, Vascular endothelial Growth Factor [VEGF], p27, and ODC) in malignant and
nonmalignant samples of bladder tissue from these patients after administration of polyphenon
E.
III. To correlate EGCG levels in samples of serum, urine, and tissue from these patients.
IV. To examine the levels of other catechins (i.e., epicatechin, epicatechin gallate, and
epigallocatechin) found in polyphenon E in samples of serum, urine, and tissue from these
patients.
V. To compare the metabolism of EGCG by Catechol-O-Methyltransferase (COMT) and
Uridinediphosphate-Glucuronosyltransferase (UGT) in relation to pharmacogenetic polymorphisms
in COMT and UGT in samples of serum, urine, and tissue from these patients.
VI. To examine the changes in serum Insulin Growth Factor 1 (IGF-1) and IGFBP-3 levels after
administration of polyphenon E in these patients.
OUTLINE:
This is a multicenter study. Patients are stratified according to tumor site and disease
invasiveness (invasive vs noninvasive). Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive six oral placebo capsules once daily for 14-28 days in the absence of
unacceptable toxicity.
Arm II: Patients receive four oral polyphenon E capsules and two oral placebo capsules once
daily for 14-28 days in the absence of unacceptable toxicity.
Arm III: Patients receive six oral polyphenon E capsules once daily for 14-28 days in the
absence of unacceptable toxicity.
After completion of study treatment, patients undergo trans-urethral resection of bladder
tumor or cystectomy.
Blood, urine, and tissue samples are obtained at baseline and at the end of study treatment
for correlative laboratory studies. Samples are evaluated for pharmacokinetics of polyphenon
E using high performance liquid chromatography. Levels of epigallocatechin-3-gallate [EGCG]
and other catechins found in polyphenon E are assessed for correlation in serum, urine, and
tissue. Intermediate endpoint biomarkers are evaluated for dose-response modulation in serum
(i.e., IGF-1 and IGFBP-3) via ELISA and in bladder tissue obtained at the time of bladder
surgery (i.e., PCNA, MMP2, clusterin, VEGF, p27, and ODS) via IHC. Patients at the University
of Wisconsin undergo additional biopsy of bladder tissue for matrix-assisted laser desorption
quadrupole time-of-flight (O-MALDI-qTOF) analysis of EGCG pharmacokinetics. Tissue samples
are examined for intracellular concentration and distribution of EGCG. Genotyping studies for
pyrosequencing of UGT and COMT polymorphisms are also performed.
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