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Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity (GLUTOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087658
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

Primary Objective:

To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred.

Secondary Objective:

To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN.

To determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4.

To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale.

To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Glutamine Drug: Calcium and Magnesium Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Open-label, Phase III Study Comparing the Efficacy of Oral Glutamine and Calcium-magnesium With Calcium-magnesium Alone in the Prevention of Oxaliplatin-induced Neurotoxicity in Patients With Colorectal Cancer Treated With Oxaliplatin in Adjuvant or 1st Line Metastatic Settings.
Study Start Date : February 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Glutamine and calcium magnesium

Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.

All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.

 Drug: Glutamine
Per os

Drug: Calcium and Magnesium
Intravenous
Active Comparator: Calcium magnesium

1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.

All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.

 Drug: Calcium and Magnesium
Intravenous


Outcome Measures
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Primary Outcome Measures :
  1. Occurence of peripheral sensory neuropathy (PSN) grade 2, 3 and 4 assessed by the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) [ Time Frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm ]

Secondary Outcome Measures :
  1. Cumulative dose of oxaliplatin and time of onset when the first PSN grade 2, 3 or 4 occurs [ Time Frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm ]
  2. Dose-reduction, dose-delay and discontinuation of oxaliplatin due to PSN grade 3 or 4 [ Time Frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm ]
  3. Patient self-reported neurotoxicity scale for chronic peripheral neuropathy [ Time Frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm ]
  4. Progression Free Survival / PFS (for metastatic patients) [ Time Frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically- or cytologically- proven adenocarcinoma of the colon or rectum.
  2. Disease either in adjuvant or 1st line metastatic setting.
  3. Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2.
  4. At least 4 weeks following any major surgical procedure(s) and recovery from any surgical sequelae.
  5. Electrocardiogram (ECG) with no acute or recent changes within limit of normal range, and not presenting abnormalities contraindicating the proposed chemotherapy.

  6. Adequate liver and kidney function:

    • Total bilirubin inferior to 1.5 ULN
    • Serum creatinine inferior to 150 umol/L
    • Creatinine clearance (ClCr) superior to 45 mL/min
    • ALT/AST inferior to 3 ULN
    • Alkaline phosphatase inferior or equal to 2 ULN, unless liver metastases are present and documented at baseline by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans (inferior or equal to 3,5 ULN in that case).

  7. Adequate hematological function:

    • Neutrophils superior or equal to 1.5 x 109/L
    • Platelet count superior or equal to 100 x 109/L
    • Hemoglobin superior to 9 g/dL

Exclusion criteria:

  1. Any condition or past medical history that contra-indicates treatment with oxaliplatin, 5-fluorouracil (5-FU), leucovorin (LV) or capecitabine as reported in the approved labeling information.
  2. Previous oxaliplatin-based chemotherapy.
  3. Previous or current diagnosis of PSN.
  4. Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing PSN: carbamazepine, amitriptyline, gabapentin, phenytoin, glutathione, alpha-lipoic acid, celecoxib, amifostine, venlafaxine, vitamin B1 (thiamine), B6 (pyridoxine).
  5. History of known allergy to oxaliplatin or other platinum agents, 5-FU, LV or capecitabine.
  6. History of known allergy to glutamine or to calcium-magnesium.
  7. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
  8. Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive heart failure (New York Heart Association Classification III or IV),
  9. Serious cardiac arrhythmia, diabetes, or active infection.
  10. Concurrent active cancer originating from a primary site other than colon or rectum.
  11. Presence of any symptom suggesting brain metastasis.
  12. Patients who are pregnant or breast-feeding
  13. Patients (males and females) with reproductive potential not implementing accepted and effective method of contraception
  14. For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with known hypersensitivity to any components of the product to Chinese hamster ovary cell product or other recombinant human or humanized antibodies

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087658


Locations
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Canada
Investigational Site Number 0001
Greenfield Park, Canada, J4V2H1
Investigational Site Number 124-005
Laval, Canada, H7M3L9
Investigational Site Number 124-007
London, Canada, N6A 4L6
Investigational Site Number 124-014
Moncton, Canada
Investigational Site Number 124-006
Montreal, Canada, H1T 2M4
Investigational Site Number 124-004
Montreal, Canada, H2L 4M1
Investigational Site Number 124010
Montreal, Canada, H2W1S6
Investigational Site Number 124-011
Montreal, Canada, H2X 1P1
Investigational Site Number 124-015
Oshawa, Canada, L1G 2B9
Investigational Site Number 124-012
Ottawa, Canada, K1H8L6
Investigational Site Number 124-003
Quebec, Canada, G1R 2J6
Investigational Site Number 124-017
Rimouski, Canada, G5L5T1
Investigational Site Number 124-002
Toronto, Canada, M5G2M9
Investigational Site Number 124-016
Winnipeg, Canada, R2H2A6
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01087658    
Other Study ID Numbers: OXALI_L_03768
U1111-1116-9494 ( Other Identifier: UTN )
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neurotoxicity Syndromes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs