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

Alternate Title

Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI	NCCTG-N9945 NSABP-CI-66, N9945, NCT00026234

Objectives

1. Determine the safety and toxicity of hepatic arterial infusion with floxuridine and dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients with surgically resected liver metastases from primary colorectal carcinoma.
2. Determine the 2-year survival rate of patients treated with this regimen.
3. Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed colorectal adenocarcinoma metastatic to the liver
• No extrahepatic metastases
• Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days
  • Negative surgical margins unless surrounding normal liver tissue was ablated during surgery
  • Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment
  • No prior operative ultrasound during resection of hepatic metastases
• Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions)

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent immunotherapy
• No concurrent colony-stimulating factors during the first course of study therapy

Chemotherapy:

• No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan
  • One prior 5-FU-based regimen as neoadjuvant treatment for rectal cancer is allowed
• No prior hepatic artery infusion therapy with 5-FU or floxuridine
• No prior systemic chemotherapy for metastatic disease
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No prior or concurrent sorivudine or brivudine

Patient Characteristics:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,200/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)

Renal:

• Creatinine no greater than ULN

  OR

• Creatinine clearance greater than 60 mL/min

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Adequate oral nutrition (at least 1,500 calories/day)
• Able to withstand major operative procedure
• No dehydration
• No severe anorexia
• No frequent nausea or vomiting
• No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
• No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis

Expected Enrollment

A total of 15-75 patients will be accrued for this study within 9 months-3.25 years.

Outline

This is a multicenter study.

Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2.5 years.

Alberts SR, Mahoney MR, Donohue J, et al.: Systemic capecitabine and oxaliplatin administered with hepatic arterial infusion (HAI) of floxuridine (FUDR) following complete resection of colorectal metastases (M-CRC) confined to the liver: a North Central Cancer Treatment Group (NCCTG) phase II intergroup trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-3525, 2006.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-2511

National Surgical Adjuvant Breast and Bowel Project

Michael O'Connell, MD, Protocol chair		Ph: 412-359-8208; 866-680-0004 Email: moconnel@wpahs.org

Registry Information
Official Title		A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine (FUDR) And Dexamethasone (DXM), Alternating With Systemic Oxaliplatin (OXAL) And Capecitabine (CAPCIT) For Colorectal Carcinoma Metastatic To The Liver
Trial Start Date		2002-02-22
Registered in ClinicalTrials.gov		NCT00026234
Date Submitted to PDQ		2001-09-10
Information Last Verified		2004-08-27
NCI Grant/Contract Number		CA25224

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