Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089401
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2004-08-04
Brief Title:
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized 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 II Trial Of Isolated Hepatic Perfusion IHP With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-05
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 such as melphalan work in different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy drugs in different ways may kill more tumor cells
PURPOSE This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with unresectable colorectal cancer that has metastasized to the liver
PURPOSE This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with unresectable colorectal cancer that has metastasized to the liver
Detailed Description:
OBJECTIVES
Primary
Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treated with isolated hepatic perfusion with melphalan
Secondary
Determine the pattern of recurrence liver vs systemic in patients treated with this regimen
Determine hepatic progression-free and overall survival in patients treated with this regimen
Determine the time to hepatic and systemic progression in patients treated with this regimen
Determine quality of life QOL in patients treated with this regimen
Correlate baseline QOL with length of survival in patients treated with this regimen
OUTLINE Patients undergo a limited laparotomy to determine if extrahepatic disease that was not visualized during preoperative scanning is present Patients found to have peritoneal seeding or unresectable extrahepatic metastatic disease not previously visualized on scans do not receive isolated hepatic perfusion IHP Remaining patients undergo IHP with melphalan and hyperthermia therapy Liver perfusion continues for 1 hour
Quality of life is assessed at baseline 6 weeks and then every 3-4 months for 3 years
Patients are followed at 6 weeks every 3-4 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
Primary
Determine the response and duration of response in patients with unresectable colorectal cancer metastatic to the liver and refractory to first-line systemic chemotherapy treated with isolated hepatic perfusion with melphalan
Secondary
Determine the pattern of recurrence liver vs systemic in patients treated with this regimen
Determine hepatic progression-free and overall survival in patients treated with this regimen
Determine the time to hepatic and systemic progression in patients treated with this regimen
Determine quality of life QOL in patients treated with this regimen
Correlate baseline QOL with length of survival in patients treated with this regimen
OUTLINE Patients undergo a limited laparotomy to determine if extrahepatic disease that was not visualized during preoperative scanning is present Patients found to have peritoneal seeding or unresectable extrahepatic metastatic disease not previously visualized on scans do not receive isolated hepatic perfusion IHP Remaining patients undergo IHP with melphalan and hyperthermia therapy Liver perfusion continues for 1 hour
Quality of life is assessed at baseline 6 weeks and then every 3-4 months for 3 years
Patients are followed at 6 weeks every 3-4 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| CDR0000378323 | None | None | None |
| 04-C-0229 | None | None | None |