Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442637
Status:
UNKNOWN
Last Update Posted:
2013-12-12
First Post:
2007-02-28
Brief Title:
Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma
Sponsor:
Dutch Colorectal Cancer Group
Organization:
Dutch Colorectal Cancer Group
Study Overview
Official Title:
Maintenance Treatment With Capecitabine and Bevacizumab Versus Observation After Induction Treatment With Chemotherapy and Bevacizumab as First-line Treatment in Patients With Advanced Colorectal Carcinoma
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
ACTIVE_NOT_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:
CAIRO3
Brief Summary:
The optimal duration of systemic treatment in patients with advanced colorectal cancer is unknown
In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin capecitabine and bevacizumab induction treatment at standard doses This treatment is continued until progression or severe toxicity This regimen is compared to the effects a observation without treatment after the induction treatment
In case of disease progression induction treatment will be reintroduced
In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin capecitabine and bevacizumab induction treatment at standard doses This treatment is continued until progression or severe toxicity This regimen is compared to the effects a observation without treatment after the induction treatment
In case of disease progression induction treatment will be reintroduced
Detailed Description:
Standard 1st-line treatment for patients with advanced colorectal cancer currently consists of chemotherapy plus bevacizumab With this approach the median overall survival is approximately 20 months and progression-free survival in first-line approximately 9-11 months The optimal duration of treatment is unknown Current data suggest that the efficacy of bevacizumab is dependent on concomitant use of chemotherapy However oxaliplatin almost invariably gives rise to neuropathy after 6-8 cycles Prolonged use of capecitabine is associated with eg hand-foot syndrome Lastly the prolonged use of these agents is associated with considerable costs
Evidence mainly preclinical suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy given at MTD In this study the concept of metronomic chemotherapy is explored by administering a continuous daily instead of the usual 2 weeks-on1 week-off oral dosing regimen of low-dose capecitabine plus bevacizumab as maintenance therapy after induction combination chemotherapy given at MTD plus bevacizumab
Evidence mainly preclinical suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy given at MTD In this study the concept of metronomic chemotherapy is explored by administering a continuous daily instead of the usual 2 weeks-on1 week-off oral dosing regimen of low-dose capecitabine plus bevacizumab as maintenance therapy after induction combination chemotherapy given at MTD plus bevacizumab
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