NCT00003225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Jul 1997

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

July 21, 2004

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

November 1, 1999

Last Update Submit

July 30, 2020

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (5)

  • To assess the total dose of Irinotecan received per 6 week cycle

    6 weeks

  • To determine incidence of Irinotecan-induced leukopenia and neutropenia

    12 weeks

  • To determine the incidence of Irinotecan-induced diarrhea

    12 weeks

  • 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).

    12 weeks

  • 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.

    12 weeks

Study Arms (1)

Ethyol plus Irinotecan

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.

Drug: amifostine trihydrateDrug: irinotecan hydrochloride

Interventions

amifostine trihydrateDRUG

Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.

Also known as: Ethyol
Ethyol plus Irinotecan
irinotecan hydrochlorideDRUG

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

Ethyol plus Irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Wilshire Oncology Medical Group, Inc.

Rancho Cucamonga, California, 91730, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

AmifostineIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Diane Prager, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 21, 2004

Study Start

July 1, 1997

Primary Completion

March 1, 2000

Study Completion

June 1, 2001

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(2)