Ignite Creation Date:
2024-05-05 @ 9:29 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00890188
Status:
UNKNOWN
Last Update Posted:
2009-05-07
First Post:
2009-04-22
Brief Title:
Thalidomide and TegafurUracilUFUR in the Treatment of Advanced Colorectal Cancer
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
The Feasibility of Combing THALIDOMIDE and UFUR in the Treatment of Advanced Colorectal Cancer After Oxaliplatin-Contained Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
RECRUITING
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:
UFUR
Brief Summary:
Colorectal cancer is a major health problem in Western society contributing to a high mortality rate Treatment options for the majority of patients with metastases are limited to cytotoxic chemotherapies The first line chemotherapy containing with oxaliplatin is recommend by guideline The use of antiangiogenic agents either alone or in combination with other therapies may provide an alternative treatment modality in the management of these patients Metronomic chemotherapy refers to the close regular administration of a chemotherapeutic drug over prolonged periods The advantages of metronomic chemotherapy include reducing acute toxicities and sometimes surprisingly good activity against drug resistant tumors via antiangiogenic effect
Thalidomide is an agent which has shown potential in the treatment of hematological and solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism Tegafururacil UFUR is one of the effective chemotherapeutics reported to be an effective antiangiogenic agent in an animal model of metastatic colorectal cancers CRCs
In the present study the investigators will try to use low dose metronomic schedule of thalidomide with tegafururacil regimen to see the anti tumor efficacy in recurrent and metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy
The primary endpoints are overall response rate and clinical benefit and the secondary endpoint were to determine the progression free survival and duration of objective response the overall survival OS and to assess the safety profile This is a prospective phase II study After having checked all eligibility criteria patients will be treated with TegafurUracil TU regimen About 34 patients will be enrolled
Thalidomide is an agent which has shown potential in the treatment of hematological and solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism Tegafururacil UFUR is one of the effective chemotherapeutics reported to be an effective antiangiogenic agent in an animal model of metastatic colorectal cancers CRCs
In the present study the investigators will try to use low dose metronomic schedule of thalidomide with tegafururacil regimen to see the anti tumor efficacy in recurrent and metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy
The primary endpoints are overall response rate and clinical benefit and the secondary endpoint were to determine the progression free survival and duration of objective response the overall survival OS and to assess the safety profile This is a prospective phase II study After having checked all eligibility criteria patients will be treated with TegafurUracil TU regimen About 34 patients will be enrolled
Detailed Description:
None
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