4.0 
Patient Selection and Registration 
4.1 Eligibility 
4.1.1 Age 18 years or older with no significatnt medical problems. Nonpregnant females 
4.1.2 Metastatic colon carcinoma with measurable disease on enhanced CT or MRI. Imaging 
studies must be performed within two weeks of starting treatment. 
4.1.3 Patients must have failed or refused standard therapy. Patients receiving prior treatment, 
including chemotherapy must wait 4 weeks before starting treatment. 
4.1.4 Expected survival must be at least 3 months. 
4.1.5 Karnofsky performance of > 60%. 
4.1.6 Baseline hematology and chemistry studies: hemoglobin > 9.9 gm/dl, total granulocyte 
count > 1,999/mm 3 , platelet count > 124,000/mm 3 , BUN < 30mg/dl, creatinine < 2mg/dl, alkaline 
phosphatase and SGOT < 2x normal upper limit of normal, amylase, lipase < 1.5x upper limit of normal. 
These studies must be performed within a week prior to starting therapy. 
4.1.7 Informed Consent: All patients must be aware of the neoplastic nature of his/her disease 
and willingly consent after being informed of the procedures to be performed, the experimental nature of 
the therapy, alternatives, potential benefits, side effects, risks and discomforts. Human protection 
committee approval of this protocol and consent form is required. 
4.2 Registration 
4.2.1 All patients must be enrolled onto study through the San Diego Regional Cancer Center 
prior to starting therapy. To register a patient, contact Colette Carson, R.N. , Clinical Trials Registrar 
(619-450-5990). Please provide the following information: 
Physcian's name and phone number 
Institution's name 
Patient's name and hospital unit number 
Patient's date of birth, sex, race, height and weight 
Previous treatment (surgery, radiation therapy, chemotherapy) with dates 
(must be > 6 weeks from enrollment or patient's tumor must be 
progressing such that waiting 6 weeks is inadvisable) 
Date and results of the following tests: 
hemoglobin (must be > 9.9/gm/dl) 
platelet count (must be > 124,000/mm 3 ) 
BUN (must be < 30mg/dl) 
creatinine (must be < 2mg/dl) 
alkaline phosphatase, SGOT (must be < 2x normal upper limit) 
amylase, lipase (must be < 1.5x normal upper limit) 
4.2.2 The registrar will review the eligibilty checklist to verify patient eligibility. If the patient 
meets all criteria, the patient will be registered onto this study. 
4.2.3 The registrar will remind the person registering the new patient of the expectations 
concerning submission of data and laboratory specimens. 
Recombinant DNA Research, Volume 18 
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