Clinical Trial Information
Protocol: Alliance – A221805
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
Eligibility:
- Stage II-III colorectal cancer patients scheduled to receive oxaliplatin 510 mg/m² (cumulative dose) over 12 weeks as a component of adjuvant FOLFOX treatment, in which patients are scheduled to receive oxaliplatin 85 mg/m² every 2 weeks for 12 weeks (i.e., 6 cycles), or adjuvant CAPOX treatment, in which patients are scheduled to receive oxaliplatin 130 mg/m² every 3 weeks for 12 weeks (i.e., 4 cycles).
- No prior neurotoxic chemotherapy.
- No pre-existing clinical or pre-clinical peripheral neuropathy from any cause.
- Comorbid conditions: Patients with the following comorbid conditions are not eligible: a. History of seizure disorder b. Narrow-angle glaucoma c. History of suicidal thoughts d. Symptoms of or a history of schizophrenia, bipolar disease, and/or a major depression e. A serious eating disorder such as bulimia or anorexia f. Known diagnosis of ethanol (ETOH) addiction/dependence within the past 10 years.
- Age ≥ 25 years.
- ECOG Performance Status 0-2.