Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	ACOSOG-Z05032 ACOSOG-Z05032, NCT00063960

Objectives

1. 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.
2. Determine the overall survival of patients treated with this regimen.
3. Determine the time to any hepatic recurrence or progression in patients treated with this regimen.

Entry 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

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

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent adjuvant radiotherapy to the pelvis
• No other concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent systemic therapy

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/mm³
• Absolute granulocyte count at least 1,500/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Yuman Fong, MD, Protocol chair		Ph: 212-639-2016; 800-525-2225 Email: fongy@mskcc.org

Registry Information
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
Trial Start Date		2003-08-15
Trial Completion Date		2004-12-17
Registered in ClinicalTrials.gov		NCT00063960
Date Submitted to PDQ		2003-05-13
Information Last Verified		2005-12-01
NCI Grant/Contract Number		CA76001

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