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Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
amifostine trihydrate
irinotecan hydrochloride
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • Wilshire Oncology Medical Group, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ethyol plus Irinotecan

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the total dose of Irinotecan received per 6 week cycle
To determine incidence of Irinotecan-induced leukopenia and neutropenia
To determine the incidence of Irinotecan-induced diarrhea
To determine the response rate for patients with metastatic colorectal carcinoma receiving Irinotecan and Ethyol on this dosing schedule (as measured by time response, duration of response time to progression, time of treatment failure survival).
To determine the clinical benefit of intravenous Irinotecan and Ethyol in patients with colorectal cancer, as measured by performance status, analgesic consumption, quality of life and survival.

Full Information

First Posted
November 1, 1999
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
ALZA
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1. Study Identification

Unique Protocol Identification Number
NCT00003225
Brief Title
Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Official Title
Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
March 2000 (Actual)
Study Completion Date
June 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
ALZA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethyol plus Irinotecan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
amifostine trihydrate
Other Intervention Name(s)
Ethyol
Intervention Description
Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Description
10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV. Administered every 14 days for 3 cycles
Primary Outcome Measure Information:
Title
To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To assess the total dose of Irinotecan received per 6 week cycle
Time Frame
6 weeks
Title
To determine incidence of Irinotecan-induced leukopenia and neutropenia
Time Frame
12 weeks
Title
To determine the incidence of Irinotecan-induced diarrhea
Time Frame
12 weeks
Title
To determine the response rate for patients with metastatic colorectal carcinoma receiving Irinotecan and Ethyol on this dosing schedule (as measured by time response, duration of response time to progression, time of treatment failure survival).
Time Frame
12 weeks
Title
To determine the clinical benefit of intravenous Irinotecan and Ethyol in patients with colorectal cancer, as measured by performance status, analgesic consumption, quality of life and survival.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Prager, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States

12. IPD Sharing Statement

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Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer

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