A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.
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.
- 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
- 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
- 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
- Life expectancy longer than 6 months
- 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
- 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.