Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408772
Status:
WITHDRAWN
Last Update Posted:
2017-06-09
First Post:
2006-12-06
Brief Title:
Oxaliplatin Capecitabine and Bevacizumab Followed By Surgery andor Radiofrequency Ablation in Patients With Colorectal Cancer
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Efficacy of Neoadjuvant XELOXAVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic ResectionRadiofrequency
Status:
WITHDRAWN
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual
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 such as oxaliplatin and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Radiofrequency ablation uses a high-frequency electric current to kill tumor cells Giving chemotherapy and bevacizumab before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab followed by surgery andor radiofrequency ablation works in treating patients with colorectal cancer that has spread to the liver and cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab followed by surgery andor radiofrequency ablation works in treating patients with colorectal cancer that has spread to the liver and cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Evaluate the conversion rate of nonresectable disease to resectable disease in patients with nonresectable liver metastases secondary to colorectal adenocarcinoma treated with neoadjuvant therapy comprising oxaliplatin capecitabine and bevacizumab followed by hepatic resection andor radiofrequency ablation
Evaluate progression-free survival of patients treated with this regimen
Secondary
Determine disease-free and overall survival of patients treated with this regimen
Determine the toxicities of this regimen in these patients
OUTLINE
Neoadjuvant therapy Patients receive oxaliplatin IV over 2 hours and bevacizumab IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity or until conversion to resectable disease
Surgery andor radiofrequency ablation RFA Patients undergo hepatic resection with or without RFA when tumor is deemed resectable Patients with stable 8 lesions and unresectable disease undergo laparoscopic or percutaneous RFA RFA repeats once 4-6 weeks later
Adjuvant therapy Beginning 6-8 weeks after surgery andor RFA patients may receive adjuvant therapy comprising oxaliplatin capecitabine and bevacizumab as in neoadjuvant therapy for up to 4 courses
After completion of study treatment patients are followed every 4 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Evaluate the conversion rate of nonresectable disease to resectable disease in patients with nonresectable liver metastases secondary to colorectal adenocarcinoma treated with neoadjuvant therapy comprising oxaliplatin capecitabine and bevacizumab followed by hepatic resection andor radiofrequency ablation
Evaluate progression-free survival of patients treated with this regimen
Secondary
Determine disease-free and overall survival of patients treated with this regimen
Determine the toxicities of this regimen in these patients
OUTLINE
Neoadjuvant therapy Patients receive oxaliplatin IV over 2 hours and bevacizumab IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity or until conversion to resectable disease
Surgery andor radiofrequency ablation RFA Patients undergo hepatic resection with or without RFA when tumor is deemed resectable Patients with stable 8 lesions and unresectable disease undergo laparoscopic or percutaneous RFA RFA repeats once 4-6 weeks later
Adjuvant therapy Beginning 6-8 weeks after surgery andor RFA patients may receive adjuvant therapy comprising oxaliplatin capecitabine and bevacizumab as in neoadjuvant therapy for up to 4 courses
After completion of study treatment patients are followed every 4 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000517440 | OTHER | UC Davis | None |
| UCDCC131 | OTHER | None | None |