A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Amifostine
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
Intervention MeSH terms: Leucovorin; Oxaliplatin; Levoleucovorin; Amifostine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oxaliplatin-induced Neuropathy; Colon and rectum

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.
    

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