Trial Outcomes & Findings for Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer (NCT NCT00666562)
NCT ID: NCT00666562
Last Updated: 2017-11-17
Results Overview
Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
up to 28 days
Results posted on
2017-11-17
Participant Flow
Participants were recruited during a 4 year period by staff at 5 participating institutions (both University hospitals and community clinics).
Participant milestones
| Measure |
Arm I (Placebo)
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
|
Overall Study
COMPLETED
|
11
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Placebo)
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Concomitant Medication
|
0
|
1
|
0
|
Baseline Characteristics
Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Placebo)
n=11 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=10 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Age, Continuous
|
70.00 years
STANDARD_DEVIATION 7.04 • n=93 Participants
|
65.20 years
STANDARD_DEVIATION 9.50 • n=4 Participants
|
66.20 years
STANDARD_DEVIATION 9.55 • n=27 Participants
|
67.23 years
STANDARD_DEVIATION 8.69 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
31 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: up to 28 daysComparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.
Outcome measures
| Measure |
Arm I (Placebo)
n=9 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=8 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=8 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
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 ng/mL
Standard Error 0.00
|
0.50 ng/mL
Standard Error 1.42
|
1.72 ng/mL
Standard Error 3.11
|
—
|
SECONDARY outcome
Timeframe: up to 28 daysPopulation: Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.
Outcome measures
| Measure |
Arm I (Placebo)
n=10 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=7 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Levels of EGCG in Malignant Bladder Tissue
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
2.54 ng/mL
Standard Deviation 2.92
|
—
|
SECONDARY outcome
Timeframe: up to 28 daysOutcome measures
| Measure |
Arm I (Placebo)
n=11 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=8 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
PCNA
|
0.41 optical density
Standard Deviation 0.052
|
0.38 optical density
Standard Deviation 0.061
|
0.35 optical density
Standard Deviation 0.052
|
—
|
|
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
MMP2
|
0.16 optical density
Standard Deviation 0.026
|
0.18 optical density
Standard Deviation 0.054
|
0.16 optical density
Standard Deviation 0.069
|
—
|
|
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
Clusterin
|
0.074 optical density
Standard Deviation 0.032
|
0.061 optical density
Standard Deviation 0.020
|
0.046 optical density
Standard Deviation 0.013
|
—
|
|
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
VEGF
|
0.011 optical density
Standard Deviation 0.0065
|
0.021 optical density
Standard Deviation 0.0173
|
0.013 optical density
Standard Deviation 0.0066
|
—
|
|
Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
p27
|
0.36 optical density
Standard Deviation 0.080
|
0.35 optical density
Standard Deviation 0.090
|
0.31 optical density
Standard Deviation 0.057
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to day 28Population: Analysis was not able to be completed for 2 participants in Arm I.
Outcome measures
| Measure |
Arm I (Placebo)
n=9 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=8 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA
Baseline
|
135.06 ng/mL
Standard Deviation 22.64
|
122.22 ng/mL
Standard Deviation 37.49
|
132.12 ng/mL
Standard Deviation 15.12
|
—
|
|
Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA
End of Study
|
131.86 ng/mL
Standard Deviation 15.59
|
124.22 ng/mL
Standard Deviation 38.06
|
132.27 ng/mL
Standard Deviation 27.77
|
—
|
SECONDARY outcome
Timeframe: up to 28 daysPopulation: Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.
Outcome measures
| Measure |
Arm I (Placebo)
n=10 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=7 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples
epicatechin gallate (ECG)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples
epicatechin (EC)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples
epigallocatechin (EGC)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.60 ng/mL
Standard Deviation 1.58
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 28 daysPopulation: Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.
The difference between the amount at the end of study (up to 28 days) from baseline.
Outcome measures
| Measure |
Arm I (Placebo)
n=9 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Absolute Change for Baseline From EGCG in Serum Samples
|
0.28 ng/mL
Standard Deviation 1.11
|
82.33 ng/mL
Standard Deviation 83.66
|
85.37 ng/mL
Standard Deviation 76.34
|
—
|
SECONDARY outcome
Timeframe: At BaselinePopulation: This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed on 4 participants.
Outcome measures
| Measure |
Arm I (Placebo)
n=6 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=11 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=8 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)
Plasma
|
4.12 ng/mL
Standard Deviation 4.80
|
0.57 ng/mL
Standard Deviation 1.89
|
2.48 ng/mL
Standard Deviation 3.48
|
—
|
|
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)
Serum
|
0.00 ng/mL
Standard Deviation 0.00
|
0.69 ng/mL
Standard Deviation 1.82
|
0.43 ng/mL
Standard Deviation 1.21
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 28 daysPopulation: Analysis was not able to be completed for 2 participants in Arm I.
Outcome measures
| Measure |
Arm I (Placebo)
n=9 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=8 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Serum IGFBP-3 Levels Assessed by ELISA
Baseline
|
1918.31 ng/mL
Standard Deviation 607.16
|
1679.61 ng/mL
Standard Deviation 556.59
|
1824.86 ng/mL
Standard Deviation 559.58
|
—
|
|
Serum IGFBP-3 Levels Assessed by ELISA
End of Study
|
2020.31 ng/mL
Standard Deviation 701.46
|
1800.08 ng/mL
Standard Deviation 490.92
|
1624.03 ng/mL
Standard Deviation 611.89
|
—
|
SECONDARY outcome
Timeframe: up to 28 daysPopulation: Analysis was not able to be completed for 2 participants in Arm I and 2 participants in Arm III.
Outcome measures
| Measure |
Arm I (Placebo)
n=9 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=8 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=8 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples
epigallocatechin (EGC)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.20 ng/mL
Standard Deviation 0.55
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples
epicatechin gallate (ECG)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples
epicatechin (EC)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.20 ng/mL
Standard Deviation 0.55
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 28 daysPopulation: Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.
The difference between the amount at the end of study (up to 28 days) from baseline.
Outcome measures
| Measure |
Arm I (Placebo)
n=8 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples
epicatechin gallate (ECG)
|
0.00 ng/mL
Standard Deviation 0.00
|
1.13 ng/mL
Standard Deviation 1.78
|
1.49 ng/mL
Standard Deviation 2.13
|
—
|
|
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples
epicatechin (EC)
|
0.52 ng/mL
Standard Deviation 1.46
|
2.41 ng/mL
Standard Deviation 3.15
|
5.33 ng/mL
Standard Deviation 6.78
|
—
|
|
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples
Epigallocatechin (EGC)
|
0.20 ng/mL
Standard Deviation 0.55
|
3.60 ng/mL
Standard Deviation 3.21
|
12.16 ng/mL
Standard Deviation 11.09
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 28 daysPopulation: Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.
The difference between the amount at the end of study (up to 28 days) from baseline.
Outcome measures
| Measure |
Arm I (Placebo)
n=9 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples
epicatechin gallate (ECG)
|
0.17 ng/mL
Standard Deviation 0.52
|
8.38 ng/mL
Standard Deviation 11.03
|
8.62 ng/mL
Standard Deviation 9.14
|
—
|
|
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples
epicatechin (EC)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.97 ng/mL
Standard Deviation 1.97
|
0.31 ng/mL
Standard Deviation 0.66
|
—
|
|
Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples
epigallocatechin (EGC)
|
0.00 ng/mL
Standard Deviation 0.00
|
6.93 ng/mL
Standard Deviation 10.06
|
3.46 ng/mL
Standard Deviation 4.04
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to 28 daysPopulation: Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.
The difference between the amount at the end of study (up to 28 days) from baseline.
Outcome measures
| Measure |
Arm I (Placebo)
n=8 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Absolute Change for Baseline of EGCG in Urine Samples
|
0.00 ng/mL
Standard Deviation 0.00
|
1.93 ng/mL
Standard Deviation 0.98
|
3.38 ng/mL
Standard Deviation 1.60
|
—
|
SECONDARY outcome
Timeframe: At BaselinePopulation: This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed for 4 participants.
Outcome measures
| Measure |
Arm I (Placebo)
n=2 Participants
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=7 Participants
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=15 Participants
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
7/7 Genotype
n=1 Participants
Genotype of the UGT in EGCG
|
|---|---|---|---|---|
|
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)
Plasma
|
2.97 ng/mL
Standard Deviation 4.20
|
2.09 ng/mL
Standard Deviation 3.75
|
2.02 ng/mL
Standard Deviation 3.58
|
0.00 ng/mL
Standard Deviation 0.00
|
|
Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)
Urine
|
1.72 ng/mL
Standard Deviation 2.43
|
0.86 ng/mL
Standard Deviation 2.27
|
0.10 ng/mL
Standard Deviation 0.40
|
0.00 ng/mL
Standard Deviation 0.00
|
Adverse Events
Arm I (Placebo)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (800mg Polyphenon E, Placebo)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm III (1200mg Polyphenon E)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Placebo)
n=11 participants at risk
Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm II (800mg Polyphenon E, Placebo)
n=10 participants at risk
Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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.
defined green tea catechin extract: Given orally
placebo: Given orally
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Arm III (1200mg Polyphenon E)
n=10 participants at risk
Patients receive six oral 1200mg 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.
defined green tea catechin extract: Given orally
therapeutic conventional surgery: Undergo surgery
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Cardiac disorders
Hypertension
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausa
|
0.00%
0/11
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
taste alteration
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Urinary Tract infection
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Immune system disorders
imb
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycemia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
photophobia
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/11
|
10.0%
1/10 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
anal pain
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
extremity limb pain
|
0.00%
0/11
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
headache
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
40.0%
4/10 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
10.0%
1/10 • Number of events 3
|
|
Renal and urinary disorders
kidney pain
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
0.00%
0/11
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
pelvis pain
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60