Clinical trial · Interventional
A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer
Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients With Colorectal Cancer
NCT00601198CI-TRIAL-00068418terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding support withdrawn
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Period
- description
- 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.
- interventionNames
- Drug: Amifostine
Primary outcomes (1)
- measure
- Test Drug in 28 Patients and Assess PSN. If 5 or More Have Grade 3 & 4 PSN, Trial Will be Terminated.
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.