A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: Amifostine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Leslie Oleksowicz, MD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
UC Cancer Center, Phone: 513-584-7698
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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%
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
UC Cancer Center, Phone: 513-584-7698
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
UC Cancer Center, Phone: 513-584-7698
Leslie Oleksowicz, MD, Principal Investigator
Additional Information
Starting date: October 2006
Ending date: October 2012
Last updated: September 28, 2009
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