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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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

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Trial Information

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


- 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

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 28-94 patients (14-47 patients per stratum) will be accrued
for this study within 2 years.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy

- Not specified


- 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


- 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


- Creatinine no greater than 1.5 times ULN

- Calcium less than 1.3 times ULN


- 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


Biologic therapy

- No concurrent immunologic or biologic therapy


- 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

Endocrine therapy

- Not specified


- No concurrent adjuvant radiotherapy to the pelvis

- No other concurrent radiotherapy


- See Disease Characteristics


- No other concurrent systemic therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Yuman Fong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • stage IV rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Central Baptist Hospital Lexington, Kentucky  40503
Integris Oncology Services Oklahoma City, Oklahoma  73112
University Medical Group Providence, Rhode Island  02908-4735