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

NCT00601198 | Terminated Phase 2 Results

• 1 other identifier: ETH190-06
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Oxaliplatin-induced Neuropathy; Colon and rectum

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

Treatment Period

EXPERIMENTAL

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.

Drug: Amifostine

Interventions

Amifostine 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

Also known as: Flurouracil (5-FU), Leucovorin calcium (LV), Oxaliplatin, Bevacizumab

Treatment Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• MedImmune LLC: collaborator
• AstraZeneca: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Amifostine; Fluorouracil; Leucovorin; Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Alison Kastl, Director of Clinical Trials
• Organization: University of Cincinnati

kastla@ucmail.uc.edu

813-584-0436

Study Officials

• Michelle Marcum

  University of Cincinnati

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of University of Cincinnati Cancer Center

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: October 1, 2006
• Primary Completion: January 13, 2010
• Study Completion: January 13, 2010
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Locations

US (1)