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A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.

Phase 2
18 Years
Not Enrolling
Colorectal Carcinoma, Neoplasms, Colorectal, Colorectal Cancer, Colorectal Tumors, Metastasis

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Trial Information

A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.

This is a phase II , open-label, non randomized study of oral glutamine administration to
evaluate oxaliplatin pharmacokinetics, and to prevent oxaliplatin neurotoxicity in patients
with metastatic colorectal cancer.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To evaluate potential pharmacokinetic interactions between oxaliplatin and glutamine at 30g and 40g in patients with metastatic colorectal cancer.

Outcome Time Frame:

Post cycle 2 and cycle 3

Safety Issue:


Principal Investigator

Michael Sawyer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Colorectal Carcinoma
  • Neoplasms, Colorectal
  • Colorectal Cancer
  • Colorectal Tumors
  • Metastasis
  • glutamine
  • oxaliplatin
  • adverse effects
  • Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neurotoxicity Syndromes