Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed no age specified MDA-DM-8491 NCI-V85-0136

Objectives

I.  Compare response rate and response duration in patients with colorectal 
cancer metastatic to the liver who are treated with hepatic arterial infusion 
(HAI) of cis-platinum plus fluorodeoxyuridine vs. HAI of fluorodeoxyuridine 
alone.
II.  Compare survival among patients treated with HAI of cis-platinum plus 
fluorodeoxyuridine vs. HAI of fluorodeoxyuridine alone.
III.  Compare the toxicities of the two protocol therapies.
IV.  Compare the pharmacokinetics of cis-platinum given by arterial infusion 
according to this protocol and cis-platinum given with Ivalon embolization 
according to an Ivalon cis-platinum embolization protocol.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic proof of 
adenocarcinoma of the colon with evidence of measurable metastatic disease to 
the liver.  The hepatic arterial anatomy should be compatible with 
percutaneous or surgical arterial catheter placement.  Patients should have 
exclusive hepatic metastases determined by CT, ultrasound, chest x-ray, etc., 
before surgery.  Minimal intra-abdominal disease (1-2 abdominal lymph nodes 
less than 3 cm in diameter) identified during laparotomy for catheter 
placement will not constitute a contraindication for inclusion on protocol.  
Eligible patients must have a Zubrod performance status of 2 or less, a 
bilirubin of 2 mg/dl or less, a serum creatinine of 1.5 mg/dl or less, and 
serum albumin of at least 2.8 g/dl; only patients with a serum creatinine of 
1.5 mg/dl or less and a creatinine clearance of at least 60 ml/min are 
eligible.  Prior radiotherapy or systemic chemotherapy is allowed; prior 
exposure to cis-platinum or 5-fluorouracil, prior liver irradiation, or 
hepatic arterial infusion of chemotherapy is not allowed (per April 1985 
amendment, prior adjuvant 5-fluorouracil is allowed).

Expected Enrollment

47 patients per arm are required for a one-tailed analysis and 60 per arm for 
a two-tailed analysis.

Outline

Randomized study.
Arm I:  2-Drug Hepatic Arterial Infusion Chemotherapy.  Floxuridine, 
Fluorodeoxyuridine, FUdR, NSC-27640; Cisplatin, cis-Platinum, CACP, NSC-119875.
Arm II:  Single-agent Hepatic Arterial Infusion Chemotherapy.  FUdR.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Yehuda Patt, MD, Protocol chair(Contact information may not be current)		Ph: 713-792-6161; 800-392-1611