Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer

Completed · Phase 1

Conditions studied: Colon Cancer, Rectal Cancer

In brief

The purpose of this study is to see how well patients tolerate the side effects of treatment with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used together are a useful way of treating cancer. We have studied these drugs and know the best doses of each when they are used alone. We do not yet know how well the drugs work with each other. This study will tell us the best doses of each drug when they are given over the same period of time.

Key facts

Study ID

NCT00695201

Run by

Memorial Sloan Kettering Cancer Center

People needed

52

Starts

2000-08-01

Expected to finish

2021-06-28

Last updated by the study team

2021-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 MSKCC.
• Patient's liver metastases must be deemed unresectable and comprise <70% of the liver parenchyma.
• A patient may have had prior chemotherapy or be previously untreated.
• Patient may not have received prior treatment with FUDR or >2 doses of Oxaliplatin.
• KPS > or = to 60%.
• WBC > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within 14 days of registration.
• Creatinine < or = to 1.5 mg/dl within 14 days of registration.
• Total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.

You may not qualify if…

• No active concurrent malignancies: except a patient's potentially resectable colorectal primary.
• Patient must not have obstruction of GI or GU tract.
• Patient must not have current, symptomatic peripheral sensory neuropathy.
• No prior radiation to liver.
• No active infection, ascites, or hepatic encephalopathy.
• Age ≥ 18 years.
• Female patients cannot be pregnant or lactating.
• Signed informed consent.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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