Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019760
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2007-03-02
Brief Title:
Isolated Hepatic Perfusion With Melphalan Followed By Chemotherapy in Treating Patients With Unresectable Colorectal Cancer That is Metastatic to the Liver
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Study of Isolated Hepatic Perfusion With Melphalan Followed By Postoperative Hepatic Arterial Chemotherapy in Patients With Unresectable Colorectal Cancer Metastatic to 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
PURPOSE Phase II trial to study the effectiveness of melphalan given as an isolated hepatic perfusion followed by chemotherapy infused into the liver in patients who have unresectable colorectal cancer that is metastatic to the liver
PURPOSE Phase II trial to study the effectiveness of melphalan given as an isolated hepatic perfusion followed by chemotherapy infused into the liver in patients who have unresectable colorectal cancer that is metastatic to the liver
Detailed Description:
OBJECTIVES I Determine the response rate and response duration in patients with unresectable colorectal cancer metastatic to the liver treated with isolated hepatic perfusion with melphalan followed by postoperative hepatic arterial chemotherapy
II Determine the patterns of recurrence in this patient population with this treatment regimen
III Evaluate the disease-free survival and overall survival in these patients
IV Evaluate health related quality of life and determine whether baseline correlates with the length of survival
PROTOCOL OUTLINE Patients undergo surgery and hyperthermic isolated hepatic perfusion with melphalan given intra-arterially over 60 minutes
At six weeks post-hepatic perfusion patients receive floxuridine and leucovorin calcium intra-arterially as a continuous infusion over 14 days Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to study and then at each followup visit Patients are followed every 3-4 months for 3 years and then every 6 months thereafter or until disease progression
PROJECTED ACCRUAL
A total of 50 patients will be accrued for this study
II Determine the patterns of recurrence in this patient population with this treatment regimen
III Evaluate the disease-free survival and overall survival in these patients
IV Evaluate health related quality of life and determine whether baseline correlates with the length of survival
PROTOCOL OUTLINE Patients undergo surgery and hyperthermic isolated hepatic perfusion with melphalan given intra-arterially over 60 minutes
At six weeks post-hepatic perfusion patients receive floxuridine and leucovorin calcium intra-arterially as a continuous infusion over 14 days Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to study and then at each followup visit Patients are followed every 3-4 months for 3 years and then every 6 months thereafter or until disease progression
PROJECTED ACCRUAL
A total of 50 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 |
|---|---|---|---|
| CDR0000067199 | None | None | None |
| 99-C-0093 | None | None | None |