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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00601198
Recruitment Status : Terminated (Funding support withdrawn)
First Posted : January 25, 2008
Last Update Posted : March 23, 2010
MedImmune LLC
Information provided by:
University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Amifostine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: 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
Other Names:
  • Flurouracil (5-FU)
  • Leucovorin calcium (LV)
  • Oxaliplatin
  • Bevacizumab

Primary Outcome Measures :
  1. Test drug in 28 patients. Trial will be terminated if 5 or more have grade 3 & 4 PSN. Will continue & add patients if 4 or fewer patients with grade 3 & 4 toxicity out of 28. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Addition 69 patients will be studied. If total number of cumulative PSN is > or equal to 14, drug will be rejected. If less than 14 cases of cumulative PSN, declare drug effective in reducing 3rd & 4 grade toxicity by 50% [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00601198

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
MedImmune LLC
Principal Investigator: Leslie Oleksowicz, MD University of Cincinnati

Responsible Party: University of Cincinnati Identifier: NCT00601198     History of Changes
Other Study ID Numbers: ETH190-06
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: March 23, 2010
Last Verified: March 2010

Keywords provided by University of Cincinnati:
Oxaliplatin-induced Neuropathy
Colon and rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs