Trial details

Trial short name: HAIP-6192

Official title: A Phase II Study of the Rate of Conversion to Complete Resection in Patients with Initially Inoperable Hepatic-Only Metastases From Colorectal Cancer After Treatment With Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination with Best Systemic Chemotherapy

Principal Investigator: Dr. Paul Karanicolas

Cancer type: Gastrointestinal
Cancer location: Colorectal
Disease stage: Advanced Cancer
Trial phase: Phase 2
Intervention: Other: Liver Pump

Registration #: Canadian Cancer Trials

Trial description:
The purpose of this study is to evaluate the effectiveness of a liver pump with the drug floxuridine in patients who have colorectal cancer with liver metastases (the cancer has spread to the liver). Patients with colorectal cancer with liver metastases (that are unable to be removed by surgery) and who have completed chemotherapy may be able to participate. All patients participating in this study will receive treatment with a liver pump and the study drug floxuridine as well as additional chemotherapy. A liver pump is a metal pump that is surgically placed in the patient’s abdomen which gives chemotherapy directly to the liver.

Inclusion Criteria: • History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease Confirmation of diagnosis must be performed at Sunnybrook Research Institute by pathology review. (Note: if disease not SRI confirmed prior to pump placement, a liver biopsy will be taken in surgery to confirm metastatic colon cancer.) • Physically able to tolerate major partial hepatectomy • The primary tumour may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement • Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen.) • The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist at a multidisciplinary tumor board In the event that two hepatobiliary surgeons cannot agree, a third surgeon will be consulted. Continued discrepancy will result in the patient’s case being presented at bi-weekly hepatobiliary conference for consensus opinion. Inoperable metastases are defined as: Requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage * • Patient’s liver metastases must comprise <70% of the liver parenchyma. • Female patients of child-bearing age must undergo a pregnancy test and have a negative result • A patient must have received prior systemic chemotherapy for metastatic disease • KPS >60%. • Within 14 days of registration: WBC >3X10E9/L ANC ≥ 1.5x10E9/L Platelet count >100x10E9/L INR < 1.5 HGB ≥ 90 g/L Creatinine < 1.5 mg/dl within 14 days of registration. Total serum bilirubin <25.6 umol/L within 14 days of registration. • Age ≥ 18 years • Signed informed consent • Subject’s willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments. Exclusion Criteria: • Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration) • Patient may not have received prior treatment with FUDR (exception will be for patients who have already started FUDR therapy at MSKCC who meet all other eligibility criteria) • Active infection, ascites, hepatic encephalopathy • Active concurrent malignancies, except a patient’s potentially resectable colorectal primary. • Extrahepatic metastases • Patient must not have obstruction of GI or GU tract • Female patients who are pregnant or lactating • Patients with history of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded (history of stroke or transient ischemic attack within 6 months prior to Day 1) • Serious or non-healing active wound, ulcer, or bone fracture • Chronic daily treatment with aspirin (> 325 mg/d) or nonsteroidal anti- inflammatory medications known to inhibit the platelet function • Presence of bleeding diathesis or coagulopathy • History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure of > 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix A), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e. atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or peripheral vascular disease (Grade II or greater, see Appendix A)