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Status:

TERMINATED

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

Lead Sponsor:

NSABP Foundation Inc

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer

Metastatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 fro...

Detailed Description

OBJECTIVES: Primary * Compare progression-free interval (PFI) in patients undergoing surgical resection and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy co...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2008

    Estimated Enrollment :

    22 Patients enrolled

    Trial Details

    Trial ID

    NCT00268463

    Start Date

    January 1 2006

    End Date

    June 1 2008

    Last Update

    May 15 2013

    Active Locations (31)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (31 locations)

    1

    Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, United States, 94524-4110

    2

    City of Hope Comprehensive Cancer Center

    Duarte, California, United States, 91010-3000

    3

    Veterans Affairs Medical Center - Loma Linda (Pettis)

    Loma Linda, California, United States, 92357

    4

    Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, United States, 94596