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

July 15, 2013 updated by: National Cancer Institute (NCI)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. 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.

II. Determine the 2-year survival rate of patients treated with this regimen. III. 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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • North Central Cancer Treatment Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • Performance status - ECOG 0-1
  • Absolute neutrophil count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3
  • 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)
  • Creatinine no greater than ULN
  • Creatinine clearance greater than 60 mL/min
  • 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
  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during the first course of study therapy

  • 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
  • No concurrent radiotherapy
  • See Disease Characteristics
  • No prior or concurrent sorivudine or brivudine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment (chemotherapy)
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.
Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Drug: capecitabine
Given orally
Other Names:
  • Xeloda
  • CAPE
  • Ro 09-1978/000
Drug: floxuridine
Given intra-arterially
Other Names:
  • 5-FUDR
Drug: dexamethasone
Given intra-arterially
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity of oxaliplatin as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 2.0
Time Frame: Up to 6 months
Up to 6 months
Survival rate
Time Frame: From the date of resection, cryoablation, or radiofrequency ablation to up to 2 years
From the date of resection, cryoablation, or radiofrequency ablation to up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival time
Time Frame: Time from metastasectomy, cryoablation, or radiofrequency ablation to death due to any cause, assessed up to 3.5 years
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time from metastasectomy, cryoablation, or radiofrequency ablation to death due to any cause, assessed up to 3.5 years
Time to recurrence
Time Frame: Time from metastasectomy, cryoablation, or radiofrequency ablation to documentation of disease recurrence, assessed up to 2 years
The distribution of the disease free interval will be estimated using the method of Kaplan-Meier.
Time from metastasectomy, cryoablation, or radiofrequency ablation to documentation of disease recurrence, assessed up to 2 years
Time to treatment failure
Time Frame: From the date of metastasectomy, cryoablation, radiofrequency ablation to the date at which the patient is removed from treatment due to recurrence, toxicity, or refusal, assessed up to 3.5 years
From the date of metastasectomy, cryoablation, radiofrequency ablation to the date at which the patient is removed from treatment due to recurrence, toxicity, or refusal, assessed up to 3.5 years
Adverse events as assessed by NCI CTC version 2.0
Time Frame: Up to 3.5 years
Patterns of treatment failure, toxicity, including complications associated with the intra-arterial catheter, will be summarized in tabular form.
Up to 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

NSABP Foundation Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

November 9, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01866
  • U10CA025224 (U.S. NIH Grant/Contract)
  • N9945
  • CDR0000069011
  • NCCTG-N9945
  • NSABP-CI-66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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