Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer - Full Text View

Sponsor:	University of California, Los Angeles
Collaborators:	National Cancer Institute (NCI) ALZA
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00003225

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: amifostine trihydrate Drug: irinotecan hydrochloride	Phase I Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Amifostine Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the total dose of Irinotecan received per 6 week cycle [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To determine incidence of Irinotecan-induced leukopenia and neutropenia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To determine the incidence of Irinotecan-induced diarrhea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	23
Study Start Date:	July 1997
Study Completion Date:	June 2001
Primary Completion Date:	March 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ethyol plus Irinotecan 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.	Drug: amifostine trihydrate Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles. Other Name: Ethyol Drug: irinotecan hydrochloride 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003225

Locations

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

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

ALZA

Investigators

Study Chair:

Diane Prager, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Diane Prager, MD / Principal Investigator, UCLA
ClinicalTrials.gov Identifier:	NCT00003225 History of Changes
Other Study ID Numbers:	CDR0000066087, P30CA016042, UCLA-HSPC-970304601B, ALZA-UCLA-HSPC-970304601B, NCI-G98-1390
Study First Received:	November 1, 1999
Last Updated:	June 16, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Amifostine
Protective Agents

Irinotecan
Camptothecin
Radiation-Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012