Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer

Inclusion Criteria:

- 18 years of age or older

- ECOG 0-2

- Life expectancy of at least 12 weeks

- Pathologically confirmed diagnosis of metastatic colorectal cancer

- Measureable disease

- Have not received therapy for cancer within 4 weeks of enrollment on study

- Prior radiation therapy to the pelvis for treatment of colorectal cancer is allowed.
Radiation therapy delivered elsewhere is allowed as long as the patient has been off
treatment for at least six weeks and measurable lesions are present outside the
radiation field

- Pretreatment granulocyte count of > 1500/mm3, hemoglobin > 9.0 g/dL (without
transfusion), and platelet count of > 100,000/um

- Serum creatinine < 2.0 mg/dL

- Adequate hepatic function as documented by a serum bilirubin < 2.0 mg/dL regardless
of whether patients have liver involvement secondary to tumor. AST must be < 3x the
upper limit of normal unless the liver is involved with tumor, in which case the AST
must be < 5x institutional upper limit of normal

Exclusion Criteria:

- Prior therapy with Irinotecan

- Patients with any active or uncontrolled infection

- Patients with psychiatric disorders that would interfere with consent or follow-up

- Patients with a history of myocardial infarction within the previous six months,
congestive heart failure, or cerebrovascular disease

- History of prior malignancy except for adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for at least five years

- Presence of clinically apparent central nervous system metastases or carcinomatous
meningitis

- Patients with uncontrolled diabetes mellitus

- Any other sever concurrent disease which, in the judgment of the investigator, would
make the patient inappropriate for entry into this study

- Patients unable to stop taking antihypertensive medication 24 hour prior to
administration of Ethyol (off x 1 day)