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Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
This study is ongoing, but not recruiting participants.
First Received: November 9, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborators: National Cancer Institute (NCI)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026234
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: capecitabine
Drug: dexamethasone
Drug: floxuridine
Drug: oxaliplatin
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2002
Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the 2-year survival rate of patients treated with this regimen.
  • Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen.

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.

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026234

Locations
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
North Central Cancer Treatment Group
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Study Chair: Steven R. Alberts, MD Mayo Clinic
Study Chair: Michael J. O'Connell, MD Allegheny Cancer Center at Allegheny General Hospital
  More Information

Additional Information:
Publications:
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.

Study ID Numbers: CDR0000069011, NCCTG-N9945, NSABP-CI-66
Study First Received: November 9, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00026234     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
liver metastases
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Dexamethasone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Rectal Diseases
Neoplastic Processes
Oxaliplatin
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Dexamethasone acetate
Capecitabine
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Floxuridine
Gastrointestinal Agents
Intestinal Diseases
Glucocorticoids
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009