Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268463
Status:
TERMINATED
Last Update Posted:
2013-05-15
First Post:
2005-12-20
Brief Title:
Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery andor Ablation for Liver Metastases Due to Colorectal Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase III Clinical Trial Comparing Oxaliplatin Capecitabine and Hepatic Arterial Infusion of Floxuridine to Oxaliplatin and Capecitabine in Patients With Resected or Ablated Liver Metastases From Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to low 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 capecitabine and floxuridine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Hepatic arterial infusion uses a catheter to carry tumor-killing substances such as chemotherapy directly into the liver Giving chemotherapy in different ways may kill more tumor cells It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery andor ablation for liver metastases due to colorectal cancer
PURPOSE This randomized phase III trial is studying oxaliplatin capecitabine and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery andor ablation for liver metastases due to colorectal cancer
PURPOSE This randomized phase III trial is studying oxaliplatin capecitabine and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery andor ablation for liver metastases due to colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare progression-free interval PFI in patients undergoing surgical resection andor ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial infusion of floxuridine
Secondary
Compare overall survival and liver PFI between the two treatment groups
Assess toxicity in each of the treatment regimens
Compare self-reported symptoms between two treatment groups
Compare quality of life in each of the treatment regimens
Tertiary
Examine the prognostic worth in terms of PFI of specific molecular markers in hepatic metastases
OUTLINE This is a randomized study Patients are stratified according to intended surgical technique surgical resection alone vs cryoablation or radiofrequency ablation RFA alone vs combination of resection and ablation and prior adjuvant chemotherapy regimen chemotherapy with vs without oxaliplatin vs no chemotherapy Patients are randomized to 1 of 2 treatment arms
All patients undergo surgical resection andor hepatic cryoablation or RFA to remove a maximum of 6 colorectal hepatic metastases Patients randomized to arm II also undergo intra-arterial catheter and if applicable pump placement
Arm 1 oxaliplatin and capecitabine Within 4-6 weeks after surgery andor ablation patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
Arm 2 oxaliplatin capecitabine and hepatic arterial infusion of floxuridine Within 4-6 weeks after surgery andor ablation patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14 oxaliplatin IV over 2 hours on day 22 and oral capecitabine twice daily on days 22-35 Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity Beginning with course 5 patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 4-6 weeks after surgery or ablation approximately 18 weeks after beginning of chemotherapy and 4-6 weeks after beginning the last cycle of chemotherapy
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Primary
Compare progression-free interval PFI in patients undergoing surgical resection andor ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial infusion of floxuridine
Secondary
Compare overall survival and liver PFI between the two treatment groups
Assess toxicity in each of the treatment regimens
Compare self-reported symptoms between two treatment groups
Compare quality of life in each of the treatment regimens
Tertiary
Examine the prognostic worth in terms of PFI of specific molecular markers in hepatic metastases
OUTLINE This is a randomized study Patients are stratified according to intended surgical technique surgical resection alone vs cryoablation or radiofrequency ablation RFA alone vs combination of resection and ablation and prior adjuvant chemotherapy regimen chemotherapy with vs without oxaliplatin vs no chemotherapy Patients are randomized to 1 of 2 treatment arms
All patients undergo surgical resection andor hepatic cryoablation or RFA to remove a maximum of 6 colorectal hepatic metastases Patients randomized to arm II also undergo intra-arterial catheter and if applicable pump placement
Arm 1 oxaliplatin and capecitabine Within 4-6 weeks after surgery andor ablation patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
Arm 2 oxaliplatin capecitabine and hepatic arterial infusion of floxuridine Within 4-6 weeks after surgery andor ablation patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14 oxaliplatin IV over 2 hours on day 22 and oral capecitabine twice daily on days 22-35 Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity Beginning with course 5 patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline 4-6 weeks after surgery or ablation approximately 18 weeks after beginning of chemotherapy and 4-6 weeks after beginning the last cycle of chemotherapy
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 400 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 |
|---|---|---|---|
| U10CA012027 | NIH | None | httpsreporternihgovquickSearchU10CA012027 |