This study is being done to answer the following question: Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
Group 1 unresectable liver metastases from colorectal cancer \- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement. Group 2 resectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement. Group 3 unresectable cholangiocarcinoma \- Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Please see Detailed Description.
Please see Detailed Description.
Virginia mason medical Center
Seattle, Washington, United States
RECRUITINGNumber of patients requiring stent replacements
Time frame: 1 year
Percent frequency liver toxicity
Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity
Time frame: 1 year
Overall survival
Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first.
Time frame: 1 year
Progression free survival
Progression free survival is defined as the time from treatment initiation till the day of progression or death whichever occurs first. Patients that are alive without progression at the end of the study will be censored.
Time frame: 1 year
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Please see Detailed Description.
Please see Detailed Description.
Please see Detailed Description.
Please see Detailed Description.