Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Calcium; Camptothecin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Floxuridine; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal adenocarcinoma metastatic to the liver

• Previously treated or untreated disease

• No clinical or radiographic evidence of extrahepatic disease

• Primary tumor may be present at study registration provided it is not obstructing the intestinal lumen or is significantly bleeding

• If present, the primary tumor will be resected at the time of pump placement

• Must have inoperable liver metastases confirmed by 2-3 hepatobiliary surgeons and the assigned radiologist

• Liver metastases < 70% of the liver parenchyma

• Inoperable liver metastases is defined by one of the following:

• More than 6 metastases in a single lobe with one lesion ≥ 5 cm

• At least 6 metastases distributed diffusely in both lobes of the liver

• When a margin-negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava

• Requires a resection that leaves < 2 hepatic segments (not including the caudate lobe) behind with adequate arterial or portal inflow, venous outflow, and biliary drainage

• No ascites or hepatic encephalopathy

• No history of primary CNS tumors

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• WBC ≥ 3,000/mm^3

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• INR < 1.5

• Hemoglobin ≥ 9 g/dL

• Creatinine ≤ 1.5 mg/dL

• Total bilirubin ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Physically able to tolerate major partial hepatectomy

• No active infection

• No concurrent active malignancies, except potentially resectable primary colorectal tumor

• No bleeding diathesis or coagulopathy

• No history of serious systemic disease, including any of the following:

• Myocardial infarction within the past 6 months

• Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)

• Unstable angina

• New York Heart Association class II-IV congestive heart failure

• Unstable symptomatic arrhythmia requiring medication

• Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed

• Peripheral vascular disease ≥ grade 2

• No serious or nonhealing active wound, ulcer, or bone fracture

• No history of seizures not well controlled with standard medical therapy

• No stroke or transient ischemic attack within the past 6 months

• No concurrent obstruction of the gastrointestinal or genitourinary tract

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior radiotherapy to the pelvis

• Prior chemotherapy allowed

• No prior radiotherapy, hepatic thermal ablation, or resection (other than biopsy) to the liver

• No prior floxuridine

• No prior hepatic arterial infusion

• No concurrent chronic aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function

• No other concurrent investigational agents