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

NCT ID: NCT00601198

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-01-13

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Period

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.

Group Type: EXPERIMENTAL

Amifostine

Intervention Type: DRUG

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

Interventions

Amifostine

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

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Michelle Marcum

Director of University of Cincinnati Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Marcum

Role: STUDY_DIRECTOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

ETH190-06

Identifier Type: -

Identifier Source: secondary_id

ETH190-06

Identifier Type: -

Identifier Source: org_study_id