Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells.

Key facts

Study ID

NCT00026234

Run by

National Cancer Institute (NCI)

People needed

75

Starts

2002-02-01

Last updated by the study team

2013-07-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed colorectal adenocarcinoma metastatic to the liver
• No extrahepatic metastases
• Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days
• Negative surgical margins unless surrounding normal liver tissue was ablated during surgery
• Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment
• No prior operative ultrasound during resection of hepatic metastases
• Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions)
• Performance status - ECOG 0-1
• Absolute neutrophil count at least 1,200/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)
• Creatinine no greater than ULN
• Creatinine clearance greater than 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Adequate oral nutrition (at least 1,500 calories/day)
• Able to withstand major operative procedure
• No dehydration
• No severe anorexia
• No frequent nausea or vomiting
• No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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