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

Phase 1/Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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

OBJECTIVES: I. Assess the toxicity profile of irinotecan and amifostine when administered
together in patients with metastatic colorectal cancer. II. Assess the total dose of
irinotecan received per 6 week course in these patients. III. Determine the incidence of
irinotecan-induced leukopenia, neutropenia, and diarrhea in these patients. V. Determine the
response rate for this patient population.

OUTLINE: This is an open label study. Amifostine is administered by 10 minute IV infusions.
Irinotecan is administered by IV infusions 15 minutes after completion of amifostine.
Treatment is repeated every 2 weeks for 6 weeks. This 6 week course is repeated in the
absence of disease progression. Treatment may be delayed up to 2 weeks after a course to
allow for recovery from toxic effects. Patients are followed at the end of study and at 30
days after study.

PROJECTED ACCRUAL: There will be 25-30 patients accrued into this study.

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

- 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)

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Diane Prager, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

June 2001

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730