A Trial of Glutamine to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin

This is an interventional supportive care trial for Colorectal Carcinoma focused on measuring glutamine, oxaliplatin, adverse effects Read More

Study Population: The target population is patients with metastatic colorectal adenocarcinoma who are sufficiently robust to undergo at least 3 cycles of oxaliplatin based chemotherapy (mFOLFOX or XELOX) Sampling Method: Probability Sample.

Inclusion Criteria:

• Patients must hvae metastatic colorectal cancer (stage IV)
• Patients who have been treated with FOLFIRI regimen for metastatic setting may be eligible for this trial
• Patients must be ≥ 18 years
• Patients must have an Eastern Cooperative Oncology Group (EGOC) performance status 0 to 2.
• Patients must have adequate renal function of creatinine < 1.5mg/dL and a creatinine clearance > 45mL/min; patients must have adequate hepatic function with a bilirubin < 1.5mg/dL and AST (normal range 0-14 U/L) and ALT (normal range 0-49 U/L); and patients must have adequate bone marrow function with absolute neutrophil count (ANC) ≥ 1,500/цL and platelets ≥ 100,000/цL and a hemoglobin ≥ 10g/d.
• Patients must be willing and able to comply with the study protocol for the duration of the study.
• Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• The investigator is requested to advise the patient how to achieve an adequate contraception
• Life expectancy longer than 6 months

Exclusion Criteria:

• Patients who have received oxaliplatin previously
• Patients with previous of current diagnosis of peripheral sensory neuropathy
• Patients who have tested positive for HIV
• Patients with other significant medical, psychiatric disorders that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons.
• Patients who cannot swallow
• History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to LV, glutamine or to any ingredients in the formulations of the containers
• Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
• Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
• Patients with concomitant treatment with drugs/ingredients reported to have a potential activity to prevent PSN
• Patients who haven't successfully completed local therapy for previously treated CNS metastases and who haven't been discontinued with corticosteroid for > 4wks before starting chemotherapy. Patients with asymptomatic brain mets. who have no evidence of midline shift on CT/ MRI may be enrolled without initiation of local therapy for the CNS mets. Repeat scan must be preformed < 4wks to ensure no progression.