Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103298
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2005-02-07
Brief Title:
Isolated Hepatic Perfusion With Melphalan Followed by Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Isolated Hepatic Perfusion IHP and Systemic FOLFOX4 for Subjects With Metastatic Unresectable Colorectal Cancers of the Liver With 40 Hepatic Tumor Burden
Status:
COMPLETED
Status Verified Date:
2006-02
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 leucovorin oxaliplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy and giving the drugs in different ways may kill more tumor cells
PURPOSE This phase II trial is studying how well isolated hepatic perfusion with melphalan followed by combination chemotherapy works in treating patients with unresectable liver metastases from colorectal cancer
PURPOSE This phase II trial is studying how well isolated hepatic perfusion with melphalan followed by combination chemotherapy works in treating patients with unresectable liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response and duration of response in patients with previously untreated unresectable liver metastases secondary to colorectal cancer treated with isolated hepatic perfusion with melphalan followed by leucovorin calcium oxaliplatin and fluorouracil
Secondary
Determine the patterns of recurrence liver vs systemic in patients treated with this regimen
Determine progression-free and overall survival of patients treated with this regimen
Correlate health-related quality of life with length of survival of patients treated with this regimen
OUTLINE Patients undergo exploratory laparotomy Patients with evidence of carcinomatosis not previously visualized on scans but found on surgical exploration are removed from the study All other patients then undergo isolated hepatic perfusion IHP Once IHP is established melphalan is administered intra-arterially over 3-5 minutes and then circulated throughout the liver for 1 hour Approximately 6-12 weeks later patients receive systemic chemotherapy comprising oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1-2 Courses with systemic chemotherapy repeat every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after laparotomy after completion of systemic chemotherapy and then every 6 months thereafter
After completion of study treatment patients are followed every 3 months for 1 year every 3-4 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2-3 years
Primary
Determine the response and duration of response in patients with previously untreated unresectable liver metastases secondary to colorectal cancer treated with isolated hepatic perfusion with melphalan followed by leucovorin calcium oxaliplatin and fluorouracil
Secondary
Determine the patterns of recurrence liver vs systemic in patients treated with this regimen
Determine progression-free and overall survival of patients treated with this regimen
Correlate health-related quality of life with length of survival of patients treated with this regimen
OUTLINE Patients undergo exploratory laparotomy Patients with evidence of carcinomatosis not previously visualized on scans but found on surgical exploration are removed from the study All other patients then undergo isolated hepatic perfusion IHP Once IHP is established melphalan is administered intra-arterially over 3-5 minutes and then circulated throughout the liver for 1 hour Approximately 6-12 weeks later patients receive systemic chemotherapy comprising oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1-2 Courses with systemic chemotherapy repeat every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after laparotomy after completion of systemic chemotherapy and then every 6 months thereafter
After completion of study treatment patients are followed every 3 months for 1 year every 3-4 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| NCI-05-C-0025 | None | None | None |