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A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Amifostine

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Oxaliplatin-induced Neuropathy, Colon and rectum

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically-proven adenocarcinoma of the colon or rectum
AJCC stage II, III or IV
Male of female aged greater than or equal to 18 years
ECOG Performance Status (PS): 0-2
Men or women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment
If female, not pregnant or lactating. Documentation of a negative serum HCG pregnancy test for women of childbearing potential is required within 7 days prior to be considered of non-childbearing potential
In the opinion of the investigator, patients must have a life expectancy of least 6 months
At the time of study enrollment, absolute granulocyte count (AGC) must be greater than or equal to 1500/mm3, platelet count must be greater than or equal to 100,000/mm3
There must be evidence of adequate hepatic and renal function. Bilirubin less than or equal to UNL, Alkaline phosphatase less than or equal to 2.5xULN, AST less than or equal to 1.5xULN, Creatine less than or equal to 1.5xULN
Signed written informed consent obtained prior to study-specific screening procedure

Exclusion Criteria:

Any condition or past medical history that contra-indicate treatment with oxaliplatin and 5FU, as reported in the approval labeling information
Hypersensitivity to any of the study treatments (amifostine, oxaliplatin and 5FU) or ingredients
Received any investigational drug within 30 days before beginning treatment with study drug
Concomitant treatment with other investigational agents
Received prior oxaliplatin or cisplatin based chemotherapy
History of peripheral neuropathy
concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy: carbamazepine, gabapentin, phenytoin, gluthathione, alpha-lipoic acid, celecoxib, venlafaxine, vitamin B1 (thiamine), B6 (pyridoxine), ginko biloba. Multivitamins and dietary supplements are allowed. Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive hear failure (NY Heart Association Classification III or IV), serious cardiac arrhythmia, diabetes, or active infection
Concurrent active cancer originating from a primary site other than colon or rectum
Presence of any symptom suggesting brain/spinal cord metastasis

Sites / Locations

University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Period

Arm Description

The chemotherapy regimen will be given for 2 consecutive days. On day #1, pt. will be premedicated with drugs to prevent nausea and vomiting in addition to intravenous fluids. Then they will receive amifostine intravenously followed by oxaliplatin, 5FU and leucovorin. This will be followed by an infusion of 5FU given in a pump over 22 hours. If the doctor decides on giving the pt. Avastin, this will be given on day #1. On day #2, they will receive the same treatment except for oxaliplatin.

Outcomes

Primary Outcome Measures

Test Drug in 28 Patients and Assess PSN. If 5 or More Have Grade 3 & 4 PSN, Trial Will be Terminated.

There were only four participants in this study. None of which completed the questionnaires needed to assess this outcome. This study was closed by the sponsor on January 13, 2010 due to low enrollment.

Secondary Outcome Measures

Assess PSN in 69 Patients. If Total Number of Cumulative PSN is > or Equal to 14, Drug Will be Rejected.

Full Information

NCT ID

NCT00601198

First Posted

January 14, 2008

Last Updated

July 12, 2023

Sponsor

University of Cincinnati

Collaborators

MedImmune LLC, AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00601198

Brief Title

A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer

Official Title

Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients With Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Funding support withdrawn

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 13, 2010 (Actual)

Study Completion Date

January 13, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

Collaborators

MedImmune LLC, AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effect of amifostine (ETHYOL) on decreasing the rate and severity of nerve dysfunction or neuropathy (numbness and tingling in hands and feet) associated with FOLFOX chemotherapy.

Detailed Description

In addition, this study will provide information on how subjects with colorectal cancer do while receiving amifostine in combination with other chemotherapy drugs. This study will also look at the frequency of complications associated with amifostine and chemotherapy. The FOLFOX chemotherapy regimen consists of three drugs, 5-FU, leucovorin, and oxaliplatin, all given intravenously (into the vein) every 2 weeks with or without Avastin given in combination with chemotherapy. FOLFOX has been approved by the Food and Drug Administration (FDA) for the treatment of cancer of the colon or rectum. Amifostine is not a chemotherapy drug. It is approved by the Food and Drug Administration (FDA) to prevent moderate or severe dryness of the mouth caused by radiation treatment for head and neck cancer, and to prevent kidney damage caused by cisplatin chemotherapy treatment for ovarian and non-small cell lung cancer. Amifostine is not FDA approved for use in this study and is therefore considered investigational.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Oxaliplatin-induced Neuropathy, Colon and rectum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Period

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Amifostine

Other Intervention Name(s)

Flurouracil (5-FU), Leucovorin calcium (LV), Oxaliplatin, Bevacizumab

Intervention Description

Patients should be treated with oxaliplatin-based chemotherapy in combination with amifostine for 12 cycles, or until unacceptable toxicity is observed or disease progression

Primary Outcome Measure Information:

Title

Test Drug in 28 Patients and Assess PSN. If 5 or More Have Grade 3 & 4 PSN, Trial Will be Terminated.

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Assess PSN in 69 Patients. If Total Number of Cumulative PSN is > or Equal to 14, Drug Will be Rejected.

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically-proven adenocarcinoma of the colon or rectum AJCC stage II, III or IV Male of female aged greater than or equal to 18 years ECOG Performance Status (PS): 0-2 Men or women of reproductive potential must have agreed to use an effective method of contraception while on treatment and for 6 months after study treatment If female, not pregnant or lactating. Documentation of a negative serum HCG pregnancy test for women of childbearing potential is required within 7 days prior to be considered of non-childbearing potential In the opinion of the investigator, patients must have a life expectancy of least 6 months At the time of study enrollment, absolute granulocyte count (AGC) must be greater than or equal to 1500/mm3, platelet count must be greater than or equal to 100,000/mm3 There must be evidence of adequate hepatic and renal function. Bilirubin less than or equal to UNL, Alkaline phosphatase less than or equal to 2.5xULN, AST less than or equal to 1.5xULN, Creatine less than or equal to 1.5xULN Signed written informed consent obtained prior to study-specific screening procedure Exclusion Criteria: Any condition or past medical history that contra-indicate treatment with oxaliplatin and 5FU, as reported in the approval labeling information Hypersensitivity to any of the study treatments (amifostine, oxaliplatin and 5FU) or ingredients Received any investigational drug within 30 days before beginning treatment with study drug Concomitant treatment with other investigational agents Received prior oxaliplatin or cisplatin based chemotherapy History of peripheral neuropathy concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy: carbamazepine, gabapentin, phenytoin, gluthathione, alpha-lipoic acid, celecoxib, venlafaxine, vitamin B1 (thiamine), B6 (pyridoxine), ginko biloba. Multivitamins and dietary supplements are allowed. Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive hear failure (NY Heart Association Classification III or IV), serious cardiac arrhythmia, diabetes, or active infection Concurrent active cancer originating from a primary site other than colon or rectum Presence of any symptom suggesting brain/spinal cord metastasis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Marcum

Organizational Affiliation

University of Cincinnati

Official's Role

Study Director

Facility Information:

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

12. IPD Sharing Statement

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A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer

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