Phase 2
Completed N=31
Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
Source: ClinicalTrials.gov NCT00666562 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors) — 0.00; 0.50; 1.72 ng/mL — p=0.046
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors) |
0.00; 0.50; 1.72 | 0.046 sig |
| SECONDARY Levels of EGCG in Malignant Bladder Tissue |
0.00; 0.00; 2.54 | — |
| SECONDARY Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry |
0.41; 0.38; 0.35; 0.16; 0.18; 0.16 | — |
| SECONDARY Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA |
135.06; 122.22; 132.12; 131.86; 124.22; 132.27 | — |
| SECONDARY Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Absolute Change for Baseline From EGCG in Serum Samples |
0.28; 82.33; 85.37 | — |
| SECONDARY Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT) |
4.12; 0.57; 2.48; 0.00; 0.69; 0.43 | — |
| SECONDARY Serum IGFBP-3 Levels Assessed by ELISA |
1918.31; 1679.61; 1824.86; 2020.31; 1800.08; 1624.03 | — |
| SECONDARY Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples |
0.00; 0.00; 0.00; 0.00; 0.00; 0.20 | — |
| SECONDARY Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples |
0.00; 1.13; 1.49; 0.52; 2.41; 5.33 | — |
| SECONDARY Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples |
0.17; 8.38; 8.62; 0.00; 0.97; 0.31 | — |
| SECONDARY Absolute Change for Baseline of EGCG in Urine Samples |
0.00; 1.93; 3.38 | — |
| SECONDARY Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT) |
2.97; 2.09; 2.02; 0.00; 1.72; 0.86 | — |
Eligibility Criteria
Criteria:
- Diagnosis of bladder cancer
- Bladder tumor discovered on cystoscopy within the past 60 days
- Invasive or non-invasive tumor
- Primary tumor may represent either an initial diagnosis or recurrent disease of any clinical stage
- No metastatic disease
- Must be an eligible candidate for a partial cystectomy, radical cystectomy, or trans-urethral resection of bladder tumor (TURBT)
- Has not undergone any treatment for superficial or invasive bladder cancer since the diagnostic cystoscopy
- TURBT or radical cystectomy is the planned curative surgical treatment
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- More than 30 days since any prior intravesical therapy or adjuvant chemotherapy
- More than 30 days since prior bladder surgery
- Biopsies are not considered surgeries
- No prior pelvic radiotherapy
- No concurrent systemic chemotherapy for any other cancer, except nonmelanoma skin cancer
- No concurrent NSAIDs (e.g., ibuprofen, naproxen, or cyclooxygenase-2 inhibitors) except = = 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 10 g/dL
- Alkaline phosphatase = 11 mEQ/dL
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to avoid green tea beverages and green tea-containing products during study participation
- No evidence of other cancers, except nonmelanoma skin cancer
- No history of allergic reactions attributed to tea or to any of the compounds of similar chemical or biologic composition to Polyphenon E or any of the inactive ingredients in Polyphenon E capsules
- No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, Psychiatric illness/social situations that would limit study compliance
- More than 24 hours since prior and no concurrent consumption of any other green tea supplements or more than 2 cups (16 oz) of green tea either through dietary sources or through nutritional supplementation
- Topical cosmetics (i.e., lotions, shampoos, makeup) that contain green tea are allowed
- Creatinine normal
- Not pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00666562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.