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

This study has been completed.
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026234
First received: November 9, 2001
Last updated: July 15, 2013
Last verified: June 2013
  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. 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.


Condition Intervention Phase
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
Liver Metastases
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Drug: floxuridine
Drug: dexamethasone
Drug: oxaliplatin
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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):

Primary Outcome Measures:
  • Toxicity of oxaliplatin as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 2.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Survival rate [ Time Frame: From the date of resection, cryoablation, or radiofrequency ablation to up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Time Frame: Time from metastasectomy, cryoablation, or radiofrequency ablation to death due to any cause, assessed up to 3.5 years ] [ Designated as safety issue: No ]
    The distribution of survival time will be estimated using the method of Kaplan-Meier.

  • Time to recurrence [ Time Frame: Time from metastasectomy, cryoablation, or radiofrequency ablation to documentation of disease recurrence, assessed up to 2 years ] [ Designated as safety issue: No ]
    The distribution of the disease free interval will be estimated using the method of Kaplan-Meier.

  • 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 ] [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTC version 2.0 [ Time Frame: Up to 3.5 years ] [ Designated as safety issue: Yes ]
    Patterns of treatment failure, toxicity, including complications associated with the intra-arterial catheter, will be summarized in tabular form.


Enrollment: 75
Study Start Date: February 2002
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: floxuridine
Given intra-arterially
Other Name: 5-FUDR
Drug: dexamethasone
Given intra-arterially
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Drug: capecitabine
Given orally
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Principal Investigator: Steven Alberts North Central Cancer Treatment Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026234     History of Changes
Other Study ID Numbers: NCI-2012-01866, N9945, CDR0000069011, NCCTG-N9945, NSABP-CI-66, U10CA025224
Study First Received: November 9, 2001
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Colonic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Capecitabine
Oxaliplatin
Floxuridine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014