Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014352
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2001-04-10
Brief Title:
Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial Of Sequential EstramustinePaclitaxel Followed By DoxorubicinKetoconazole In Patients With Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 Combining more than one drug may kill more tumor cells Anticoagulant drugs such as warfarin may reduce the risk of blood clots
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus warfarin in treating patients who have prostate cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus warfarin in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES I Determine the safety efficacy and durability of docetaxel and estramustine followed by doxorubicin and ketoconazole in patients with high-risk androgen-independent prostate cancer II Determine whether anticoagulation with warfarin can reduce the frequency of thromboembolic complications associated with estramustine in these patients
OUTLINE Regimen A Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 3 weekly Patients also receive oral warfarin daily Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity Regimen B After completion of regimen A patients receive doxorubicin IV over 30 minutes weekly and oral ketoconazole twice daily Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 1 year
OUTLINE Regimen A Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 3 weekly Patients also receive oral warfarin daily Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity Regimen B After completion of regimen A patients receive doxorubicin IV over 30 minutes weekly and oral ketoconazole twice daily Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-G01-1927 | None | None | None |
| MSKCC-00113 | None | None | None |