A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
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, so the first doses of systemic chemotherapy will be given on Cycle 1, Day
 15, and then every 2 weeks thereafter. CT C/A/P every 2 months. A window of +/- 3 weeks for
 scans is allowed in order to accommodate patient schedules.

 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, so the first doses of systemic chemotherapy
 will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Treatment will continue
 for 6 months in the absence of toxicity or patient withdrawal. CT C/A/P every 3 months. A
 window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.

 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, so the first doses of systemic chemotherapy will be given on
 Cycle 1, Day 15, and then every 2 weeks thereafter. A CT C/A/P every 2 months during
 treatment. A window of +/- 3 weeks for scans is allowed in order to accommodate patient
 schedules.
Inclusion Criteria:

 -  History of histologically confirmed colorectal adenocarcinoma metastatic to the liver
 with no clinicalyl or radiographically confirmed extrahepatic disease (or)
 Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of
 metastatic disease that has been resected is allowed, provided there is no recurrence
 in that area prior to protocol consent)

 -  Confirmation of diagnosis must be performed at MSKCC

 -  Patient may have completely resected hepatic metastases without current evidence of
 other metastatic disease

 -  Lab values ≤14 days prior to registration:

 -  WBC ≥2.5 K/uL

 -  Platelets ≥100,000/uL

 -  Creatinine <1.7mg/dL

 -  HGB ≥ 8.5 gm/dL

 -  Total Bilirubin ≤1.5 mg/dl

 -  Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to
 this study. [Note: no chemotherapy to be given after resection of liver lesions prior
 to treatment on this study]

 -  Any investigation agent is acceptable if administered ≥3 months before planned first
 dose on this protocol

 -  KPS ≥60%

 -  Patients ≥18 years of age

 Exclusion Criteria:

 -  Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if
 competed at least 4 weeks prior to the planned first dose of treatment on protocol)

 -  Active infection, ascites, hepatic encephalopathy

 -  Female patients who are pregnant or lactating - or planning to become pregnant within
 6 months after the end of the treatment (female patients of child-bearing potential
 must have negative pregnancy test ≤72 hours before treatment start)

 -  If in the opinion of the treating investigator a patient has any serious medical
 problems which may preclude receiving this type of treatment

 -  Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis)

 -  Patients with history or known presence of primary CNS tumors, seizures not
 well-controlled with standard medical therapy, or history of stroke will also be
 excluded

 -  Serious or non-healing active wound, ulcer, or bone fracture

 -  History of other malignancy, except:

 1. Malignancy treated with curative intent and with no known active disease present
 for ≥3 years prior to registration and felt to be at low risk for recurrence by
 the treating physician

 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without
 evidence of disease

 3. Adequately treated cervical carcinoma in situ without evidence of disease

 There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the
 study results are expected to be generalizable to the Medicare beneficiary population.