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
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility 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
Sites / Locations
- Cancer Care Center at John Muir Health - Concord Campus
- City of Hope Comprehensive Cancer Center
- Veterans Affairs Medical Center - Loma Linda (Pettis)
- Kaiser Permanente Medical Center - Walnut Creek
- John Muir/Mt. Diablo Comprehensive Cancer Center
- CCOP - Christiana Care Health Services
- Washington Cancer Institute at Washington Hospital Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Central Baptist Hospital
- Louisville Oncology at Norton Cancer Center
- CCOP - Ochsner
- Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
- Saint Joseph Mercy Cancer Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Mayo Clinic Cancer Center
- Wake Forest University Comprehensive Cancer Center
- Altru Cancer Center at Altru Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- St. Luke's Cancer Network at St. Luke's Hospital
- Geisinger Medical Center
- UMC Southwest Cancer and Research Center
- Fletcher Allen Health Care - University Health Center Campus
- Virginia Oncology Associates - Hampton
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm 1: Capecitabine + Oxaliplatin
Arm 2: Floxuridine + Oxaliplatin + Capecitabine
Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 cycles in the absence of unacceptable toxicity. Beginning with cycle 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 cycles.