Clinical Trial: Oxaliplatin and Capecitabine With or Without Hepatic Arterial Infusion of Floxuridine in Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases From Colorectal Cancer

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) December 2005

Sponsors and Collaborators: National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00268463

Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Giving the drugs in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases from colorectal cancer.

PURPOSE: This randomized phase III trial is studying how well oxaliplatin, capecitabine, and hepatic arterial infusion of floxuridine works compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases from colorectal cancer.

Condition Intervention Phase
Liver Metastases
Stage IV Colon Cancer
Stage IV Rectal Cancer
Adenocarcinoma of the Colon
Adenocarcinoma of the Rectum
 Drug: capecitabine
 Drug: floxuridine
 Drug: oxaliplatin
 Procedure: adjuvant therapy
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: hepatic arterial infusion
 Procedure: hyperthermia
 Procedure: radiofrequency ablation
 Procedure: surgery
Phase III

MedlinePlus related topics:  Colorectal Cancer;   Liver Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Adjuvant Therapy Comprising Oxaliplatin and Capecitabine With Versus Without Hepatic Arterial Infusion of Floxuridine in Patients Undergoing Surgical Resection and/or Ablation for Hepatic Metastases From Colorectal Cancer

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

OBJECTIVES:

Primary

Secondary

  • Compare overall survival and liver PFI between the two treatment groups.
  • Assess toxicity in each of the treatment regimens.
  • Compare self-reported symptoms between two treatment groups.
  • Compare quality of life in each of the treatment regimens.

Tertiary

  • Examine the prognostic worth, in terms of PFI, of specific molecular markers in hepatic metastases.

OUTLINE: This is a randomized study. Patients are stratified according to intended surgical technique (surgical resection alone vs cryoablation or radiofrequency ablation [RFA] alone vs combination of resection and ablation) and prior adjuvant chemotherapy regimen (chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1 of 2 treatment arms.

All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove colorectal hepatic metastases. Patients randomized to arm II also undergo intra-arterial pump and catheter placement.

Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, 18 weeks after beginning of chemotherapy, and 4-6 weeks after completion of chemotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Histologically* or cytologically confirmed colorectal adenocarcinoma
  • No other cellular type (e.g., sarcoma, lymphoma, or carcinoid) NOTE: *If the primary colorectal tumor and the hepatic lesions have been identified at the same time and it is possible to biopsy the colorectal lesion, the patient will be eligible without histiologic confirmation of the colorectal primary cancer as long as other radiographic studies or scans document the characteristics of a colorectal cancer
  • Synchronous or metachronous metastatic disease confined to the liver
  • No more than 6 hepatic metastatic lesions that can potentially be resected or ablated
  • For patients presenting with synchronous lesion(s) in the colon and/or rectum, the primary tumors must, in the opinion of the investigator, appear to be completely resectable
  • Must be able to undergo surgery and/or ablation withing 28 days following randomization
  • No evidence of extrahepatic metastases
  • No prior colorectal metastases
  • No recurrent colorectal cancer concurrent with hepatic metastases

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 5 years, excluding their colorectal cancer
  • ECOG (Zubrod) performance status 0-1
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
  • Absolute granulocyte count ≥ 1,200/mm^3
  • Platelet count ≥ 100,000/mm^3
  • PT/INR ≤ 1.5
  • Direct bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Creatinine clearance > 50 mL/min
  • Not pregnant or lactating
  • Negative pregnancy test
  • Patients with child bearing potential must agree to use adequate contraception
  • Able to swallow oral medication
  • No preexisting chronic hepatic disease (e.g., chronic active hepatitis or cirrhosis)
  • No grade 3 or 4 anorexia or nausea
  • No vomiting ≥ grade 2
  • No clinically significant peripheral neuropathy defined as ≥ grade 2 neurosensory or neuromotor toxicity
  • No psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00268463


Study chairs or principal investigators

Lawrence D. Wagman, MD,  Study Chair,  Beckman Research Institute   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000455591; NSABP-C-09
Last Updated:  December 21, 2005
Record first received:  December 20, 2005
ClinicalTrials.gov Identifier:  NCT00268463
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10

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