Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020501
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2001-07-11
Brief Title:
Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Prospective Random Assignment Trial of Regional and Systemic Chemotherapy With or Without Initial Isolated Hepatic Perfusion for Patients With Metastatic Unresectable Colorectal Cancers of the Liver
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them in different ways may kill more tumor cells It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver
Detailed Description:
OBJECTIVES
Compare the disease-free and overall survival of patients with unresectable colorectal cancer metastatic to the liver treated with regional and systemic chemotherapy with or without isolated hepatic perfusion with melphalan
Compare the response rate and duration of response in patients treated with these regimens
Compare the patterns of recurrence liver vs systemic in patients treated with these regimens
Compare the health-related quality of life QOL of patients treated with these regimens
Determine whether baseline QOL correlates with length of survival of patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to prior chemotherapy for liver metastasis yes vs no and percentage of hepatic replacement less than 25 vs at least 25 All patients undergo laparotomy to determine final eligibility Eligible patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo hyperthermic isolated hepatic perfusion with melphalan over 60 minutes Patients then undergo placement of an intrahepatic pump or port At 6 weeks post hepatic perfusion patients receive systemic chemotherapy comprising irinotecan IV over 90 minutes on day 1 followed by fluorouracil IV over 15 minutes and leucovorin calcium CF IV over 15 minutes on days 1-3 Patients receive local chemotherapy comprising floxuridine FUDR and CF by hepatic arterial infusion HAI continuously on days 14-28
Arm II Patients undergo placement of an intrahepatic pump or port at laparotomy At 7 days post laparotomy patients receive FUDR and CF by HAI continuously for 14 days Beginning 2 weeks after completion of HAI patients receive systemic and local chemotherapy as in arm I
Treatment with combined systemic and local chemotherapy repeats every 35 days for a maximum of 6 courses Treatment with local chemotherapy alone repeats every 28 days for a maximum of 6 additional courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline postoperatively every third course of chemotherapy every 3 months for 2 years and then every 6 months thereafter
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 168 patients 84 per treatment arm will be accrued for this study within 54 months
Compare the disease-free and overall survival of patients with unresectable colorectal cancer metastatic to the liver treated with regional and systemic chemotherapy with or without isolated hepatic perfusion with melphalan
Compare the response rate and duration of response in patients treated with these regimens
Compare the patterns of recurrence liver vs systemic in patients treated with these regimens
Compare the health-related quality of life QOL of patients treated with these regimens
Determine whether baseline QOL correlates with length of survival of patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to prior chemotherapy for liver metastasis yes vs no and percentage of hepatic replacement less than 25 vs at least 25 All patients undergo laparotomy to determine final eligibility Eligible patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo hyperthermic isolated hepatic perfusion with melphalan over 60 minutes Patients then undergo placement of an intrahepatic pump or port At 6 weeks post hepatic perfusion patients receive systemic chemotherapy comprising irinotecan IV over 90 minutes on day 1 followed by fluorouracil IV over 15 minutes and leucovorin calcium CF IV over 15 minutes on days 1-3 Patients receive local chemotherapy comprising floxuridine FUDR and CF by hepatic arterial infusion HAI continuously on days 14-28
Arm II Patients undergo placement of an intrahepatic pump or port at laparotomy At 7 days post laparotomy patients receive FUDR and CF by HAI continuously for 14 days Beginning 2 weeks after completion of HAI patients receive systemic and local chemotherapy as in arm I
Treatment with combined systemic and local chemotherapy repeats every 35 days for a maximum of 6 courses Treatment with local chemotherapy alone repeats every 28 days for a maximum of 6 additional courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline postoperatively every third course of chemotherapy every 3 months for 2 years and then every 6 months thereafter
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 168 patients 84 per treatment arm will be accrued for this study within 54 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068562 | None | None | None |
| NCI-01-C-0093 | None | None | None |