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Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
floxuridine
irinotecan hydrochloride
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma Primary colorectal adenocarcinoma that has been completely resected (R0 disease) No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast Metastatic disease No more than 9 liver metastases All lesions completely resected or completely treated by ablation (with or without resection) All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava All resected lesions must have a negative surgical margin (R0) Disease progression after prior systemic irinotecan for metastatic disease allowed No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection No other prior resection of extrahepatic metastases Must have the entire liver remnant perfused with a single catheter Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Zubrod 0-2 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 mg/dL Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN) AST and ALT no greater than 2.0 times ULN No active hepatitis B or C infection No histological evidence of cirrhosis Renal Creatinine no greater than 1.5 times ULN Calcium less than 1.3 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile Medically fit to begin chemotherapy between 4 and 8 weeks after surgery Prior cancer allowed if all of the following criteria are met: Undergone potentially curative therapy for all prior malignancies No other malignancy within the past 5 years except the following: Effectively treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix that has been effectively treated by surgery alone Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone No evidence of recurrence of any prior malignancy No prior hepatic arterial infusion pump malfunction, malperfusion, or infection PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunologic or biologic therapy Chemotherapy No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection) No prior hepatic arterial infusion with fluorouracil or floxuridine Radiotherapy No concurrent adjuvant radiotherapy to the pelvis No other concurrent radiotherapy Other No other concurrent systemic therapy

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Central Baptist Hospital
  • Massachusetts General Hospital Cancer Center
  • University of Minnesota Cancer Center
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Comprehensive Cancer Center at Wake Forest University
  • Integris Oncology Services
  • University Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

floxuridine + irinotecan

Arm Description

Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

time to hepatic recurrence or progression

Full Information

First Posted
July 8, 2003
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00063960
Brief Title
Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
Official Title
A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients (Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer) Treated With Adjuvant Hepatic Arterial Infusion (HAI) FUDR Plus Systemic CPT-11
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery. PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.
Detailed Description
OBJECTIVES: Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer. Determine the overall survival of patients treated with this regimen. Determine the time to any hepatic recurrence or progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection). Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
floxuridine + irinotecan
Arm Type
Experimental
Arm Description
Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.
Intervention Type
Drug
Intervention Name(s)
floxuridine
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
overall survival
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
time to hepatic recurrence or progression
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma Primary colorectal adenocarcinoma that has been completely resected (R0 disease) No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast Metastatic disease No more than 9 liver metastases All lesions completely resected or completely treated by ablation (with or without resection) All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava All resected lesions must have a negative surgical margin (R0) Disease progression after prior systemic irinotecan for metastatic disease allowed No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection No other prior resection of extrahepatic metastases Must have the entire liver remnant perfused with a single catheter Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Zubrod 0-2 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 mg/dL Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN) AST and ALT no greater than 2.0 times ULN No active hepatitis B or C infection No histological evidence of cirrhosis Renal Creatinine no greater than 1.5 times ULN Calcium less than 1.3 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile Medically fit to begin chemotherapy between 4 and 8 weeks after surgery Prior cancer allowed if all of the following criteria are met: Undergone potentially curative therapy for all prior malignancies No other malignancy within the past 5 years except the following: Effectively treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix that has been effectively treated by surgery alone Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone No evidence of recurrence of any prior malignancy No prior hepatic arterial infusion pump malfunction, malperfusion, or infection PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunologic or biologic therapy Chemotherapy No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection) No prior hepatic arterial infusion with fluorouracil or floxuridine Radiotherapy No concurrent adjuvant radiotherapy to the pelvis No other concurrent radiotherapy Other No other concurrent systemic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuman Fong, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-9985
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7213
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Integris Oncology Services
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
University Medical Group
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4735
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

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