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

This study has been withdrawn prior to enrollment.
(abandoned)
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01157039
First received: July 2, 2010
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

The investigators hypothesize that glutamine significantly reduces the incidence and severity of peripheral neuropathy in patients receiving oxaliplatin for metastatic colorectal cancer, decreases the need for dose reduction of oxaliplatin, and it does not impair oxaliplatin efficacy or pharmacokinetics.


Condition Intervention Phase
Colorectal Carcinoma
Neoplasms, Colorectal
Colorectal Cancer
Colorectal Tumors
Metastasis
Dietary Supplement: Glutamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • To evaluate potential pharmacokinetic interactions between oxaliplatin and glutamine at 30g and 40g in patients with metastatic colorectal cancer. [ Time Frame: Post cycle 2 and cycle 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate effects of glutamine supplementation on neuropathy and diarrhea related to oxaliplatin, and on dose reductions and in patients with metastatic colorectal cancer. [ Time Frame: Post cycle 2 to 30-day follow-up visit ] [ Designated as safety issue: No ]
  • To compare the toxicity profile of glutamine and FOLFOX to historical data. [ Time Frame: Post cycle 2 to 30-day follow-up visit. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: October 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary Supplement
Arm A: At cycle 2, patients will be randomized to receive for 6 days- Glutamine 30g/day during cycle 2 and glutamine 40g/day during cycle 3
Dietary Supplement: Glutamine
Glutamine- During the first cycle of oxaliplatin based combination therapy (mFOLFOX 6 or XELOX) no patient will receive glutamine. At cycle 2, patients will be randomized to receive for 6 days either : Glutamine 30g/day during cycle 2 and glutamine 40g/day during cycle 3 (ARM A) or glutamine 40g/day at cycle 2 and glutamine 30g/day at cycle 3 (Arm B).
Other Name: L-glutamine
Experimental: Dietary supplement
Arm B: At cycle 2, patients will be randomized to receive for 6 days: Glutamine 40g/day at cycle 2 and glutamine 30g/day at cycle 3.
Dietary Supplement: Glutamine
Glutamine- During the first cycle of oxaliplatin based combination therapy (mFOLFOX 6 or XELOX) no patient will receive glutamine. At cycle 2, patients will be randomized to receive for 6 days either : Glutamine 30g/day during cycle 2 and glutamine 40g/day during cycle 3 (ARM A) or glutamine 40g/day at cycle 2 and glutamine 30g/day at cycle 3 (Arm B).
Other Name: L-glutamine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01157039

Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Study Chair: Michael Sawyer, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01157039     History of Changes
Other Study ID Numbers: 25070
Study First Received: July 2, 2010
Last Updated: October 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
glutamine
oxaliplatin
adverse effects

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Neurotoxicity Syndromes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Nervous System Diseases
Poisoning
Substance-Related Disorders
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014