A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Cetuximab; Floxuridine; Fluorouracil; Gemcitabine; Irinotecan; Oxaliplatin; Panitumumab

Criteria

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.