Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165451
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-09-09
Brief Title:
A Trial of Thalidomide Celecoxib Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Anti-Angiogenic Chemotherapy A Phase II Trial of Thalidomide Celecoxib Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
Status:
COMPLETED
Status Verified Date:
2011-07
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:
This study will use a combination of four oral drugs thalidomide cyclophosphamide etoposide and celecoxib to treat patients with relapsed or progressive cancer These drugs are expected to target the blood vessels that supply the tumors with what they need to grow
Detailed Description:
Thalidomide will be given orally every evening and the daily dose will escalate until the patient reaches a dose on which they are comfortable and will given continuously for one year
Celecoxib will be given orally twice a day and escalated as tolerated for one year
Etoposide will be given orally once a day for 21 consecutive days This medication will alternate with oral cyclophosphamide and will continue for one year
Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated above will alternate with etoposide for one year
During the treatment blood tests will be performed every three weeks except during the first 3 week cycle in which testing is performed every 2 weeks Appropriate imaging studies will be performed every 9 weeks
The duration of treatment is one year unless the side effects are too harmful or the tumor grows Treatment may be continued past one year if the drugs are well tolerated and disease progression has not occured
Celecoxib will be given orally twice a day and escalated as tolerated for one year
Etoposide will be given orally once a day for 21 consecutive days This medication will alternate with oral cyclophosphamide and will continue for one year
Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated above will alternate with etoposide for one year
During the treatment blood tests will be performed every three weeks except during the first 3 week cycle in which testing is performed every 2 weeks Appropriate imaging studies will be performed every 9 weeks
The duration of treatment is one year unless the side effects are too harmful or the tumor grows Treatment may be continued past one year if the drugs are well tolerated and disease progression has not occured
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