Overview

Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer

Status:
Terminated
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
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 tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer. PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NSABP Foundation Inc
Collaborator:
National Cancer Institute (NCI)
Treatments:
Capecitabine
Floxuridine
Oxaliplatin
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 not possible to biopsy the colorectal lesion, the patient will be
eligible without histologic 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 within 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

- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

- No other malignancy within the past 5 years except carcinoma in situ of the cervix,
melanoma in situ, basal cell or squamous cell skin cancer, or carcinoma of the colon
or rectum

- Absolute granulocyte count ≥ 1,200/mm^3

- Platelet count ≥ 100,000/mm^3

- PT/international normalized ratio (INR) ≤ 1.5 unless patient is on therapeutic doses
of anticoagulant medication

- Total bilirubin ≤ upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 ULN

- aspartate aminotransferase (AST) ≤ 2.5 times ULN

- Calculated 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:

- Prior adjuvant fluorouracil alone or in combination with levamisole, leucovorin
calcium, irinotecan hydrochloride, or oxaliplatin allowed if these regimens were
completed > 6 months ago

- No prior resection/ablation, hepatic arterial infusion therapy, or any systemic
chemotherapy for metastatic disease

- Prior excisional biopsy allowed

- No prior radiotherapy to the liver

- No concurrent bevacizumab in patients who have had pump/catheter placement receiving
hepatic arterial infusion of floxuridine

- Patients who meet specific situations outlined in the protocol and who have not
had pump placement may receive bevacizumab at the physician's discretion

- No concurrent halogenated antiviral agents such as sorivudine or brivudine in patients
receiving fluorouracil, floxuridine, or capecitabine

- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) as primary
prophylaxis for neutropenia

- Following neutropenic events, these drugs may be used at the physician's
discretion during subsequent cycles

- No other concurrent cancer therapy

- No other concurrent investigational agents