Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005828
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-06-02
Brief Title:
Green Tea Extract in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Green Tea Extract in the Treatment of Androgen-Independent Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Green tea extract contains substances that may slow the growth of certain cancers and may prevent the development of new cancers
PURPOSE Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the effectiveness and toxicity of green tea extract in patients with androgen-independent metastatic prostate cancer II Determine the response rate and response duration in patients treated with this regimen III Determine whether a decline in prostate-specific antigen PSA coincides with evidence of disease regression in these patients
OUTLINE Patients receive oral green tea extract six times daily for 4 months Patients with a 50 decline in PSA complete or partial response or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity Patients with disease progression after 4 months receive no further treatment Patients are followed every 3 months for 5 years or until disease progression If disease progression patients are followed every 6 months for 5 years
OUTLINE Patients receive oral green tea extract six times daily for 4 months Patients with a 50 decline in PSA complete or partial response or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity Patients with disease progression after 4 months receive no further treatment Patients are followed every 3 months for 5 years or until disease progression If disease progression patients are followed every 6 months for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067842 | REGISTRY | PDQ Physician Data Query | None |