Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165217
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-09-09
Brief Title:
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer
Detailed Description:
Patients will take capecitabine orally twice a day for two weeks followed by a one week break period These three week cycles will continue as long as the patient continues to benefit from the the therapy and does not experience intolerable side effects
Thalidomide will be taken orally once daily in the evening Each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects The dose will be increased in this manner until the daily dose is 600mg If side effects do develop the dose will either be held constant or decreased until the side effects resolve If the side effects do not resolve treatment will be stopped
Before starting treatment and periodically throughout the study a physical exam routine blood tests scans and x-rays will be done to monitor the bodys response to the treatment
For women patients pregnancy tests will be performed every 3 weeks while on therapy
Scans and x-rays will be performed every 9 weeks after every 3 cycles of treatment to follow the effects of the study drugs on the tumor
Thalidomide will be taken orally once daily in the evening Each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects The dose will be increased in this manner until the daily dose is 600mg If side effects do develop the dose will either be held constant or decreased until the side effects resolve If the side effects do not resolve treatment will be stopped
Before starting treatment and periodically throughout the study a physical exam routine blood tests scans and x-rays will be done to monitor the bodys response to the treatment
For women patients pregnancy tests will be performed every 3 weeks while on therapy
Scans and x-rays will be performed every 9 weeks after every 3 cycles of treatment to follow the effects of the study drugs on the tumor
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