Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006023
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2000-07-05
Brief Title:
Capecitabine in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma - Phase II Trials - Protocol 5 Capecitabine
Status:
COMPLETED
Status Verified Date:
2019-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the efficacy of capecitabine in terms of PSA response PSA response duration and time to PSA progression in patients with metastatic hormone refractory prostate cancer II Evaluate the toxicity of this treatment in these patients III Evaluate the correlation between PSA response and quality of life in these patients
OUTLINE This is a multicenter study Patients receive oral capecitabine twice daily on days 1-14 Treatment continues every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed on days 1 and 8 of the first course of treatment on day 1 of each course thereafter and at treatment failure Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive oral capecitabine twice daily on days 1-14 Treatment continues every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed on days 1 and 8 of the first course of treatment on day 1 of each course thereafter and at treatment failure Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-25 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20020 | OTHER | EU | None |
| SWS-SAKK-0800 | OTHER | None | None |