Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-26 @ 9:57 AM
Study NCT ID:
NCT00006050
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Sponsor:
UNICANCER
Organization:
Study Overview
Official Title:
Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV
Status:
COMPLETED
Status Verified Date:
2021-02
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 use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.
PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.
Detailed Description:
OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion combined with intravenous leucovorin calcium and fluorouracil in patients with liver metastases from colorectal cancer.
OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
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?: