Completed

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

What is being tested

amifostine trihydrate

+ irinotecan hydrochloride

Drug

Who is being recruted

Colonic Diseases+10

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: July 1997

See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center

Last updated: August 3, 2020

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00003225

Principal SponsorJonsson Comprehensive Cancer Center

Last updated: August 3, 2020

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColonic NeoplasmsRectal NeoplasmsColorectal Neoplasms

Criteria

10 inclusion criteria required to participate

18 years of age or older

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

ECOG 0-2

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

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9 exclusion criteria prevent from participating

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

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

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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. 10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United StatesOpen Jonsson Comprehensive Cancer Center, UCLA in Google Maps

Wilshire Oncology Medical Group, Inc.

Rancho Cucamonga, United States

Completed2 Study Centers