Colorectal NeoplasmsPhase 3GLUTOXNCT01087658
Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
A Phase 3 study testing Glutamine and Calcium and Magnesium in people with Colorectal Neoplasms, run by Sanofi at 14 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Glutamine and Calcium and Magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 14 sitesCanada
- Study dates
- Feb 2010to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically- proven adenocarcinoma of the colon or rectum.
- Disease either in adjuvant or 1st line metastatic setting.
- Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2.
- At least 4 weeks following any major surgical procedure(s) and recovery from any surgical sequelae.
- Electrocardiogram (ECG) with no acute or recent changes within limit of normal range, and not presenting abnormalities contraindicating the proposed chemotherapy.
- Adequate liver and kidney function:
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- 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).
- 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
Who cannot join
- 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.
- Previous oxaliplatin-based chemotherapy.
- Previous or current diagnosis of PSN.
- 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).
- History of known allergy to oxaliplatin or other platinum agents, 5-FU, LV or capecitabine.
- History of known allergy to glutamine or to calcium-magnesium.
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- Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
- Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive heart failure (New York Heart Association Classification III or IV),
- Serious cardiac arrhythmia, diabetes, or active infection.
- Concurrent active cancer originating from a primary site other than colon or rectum.
- Presence of any symptom suggesting brain metastasis.
- Patients who are pregnant or breast-feeding
- Patients (males and females) with reproductive potential not implementing accepted and effective method of contraception
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
Investigational Site Number 0001
Greenfield Park, J4V2H1
Investigational Site Number 124-005
Laval, H7M3L9
Investigational Site Number 124-007
London, N6A 4L6
Investigational Site Number 124-014
Moncton
Investigational Site Number 124-006
Montreal, H1T 2M4
Investigational Site Number 124-004
Montreal, H2L 4M1
Investigational Site Number 124010
Montreal, H2W1S6
Investigational Site Number 124-011
Montreal, H2X 1P1
Investigational Site Number 124-015
Oshawa, L1G 2B9
Investigational Site Number 124-012
Ottawa, K1H8L6
Investigational Site Number 124-003
Québec, G1R 2J6
Investigational Site Number 124-017
Rimouski, G5L5T1
Investigational Site Number 124-002
Toronto, M5G2M9
Investigational Site Number 124-016
Winnipeg, R2H2A6
About this study
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.
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.
Read more
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Glutamine, Calcium and Magnesium
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
Per os
Calcium and MagnesiumDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Glutamine and calcium magnesium | Experimental | 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. Receives: Drug: Glutamine; Drug: Calcium and Magnesium |
| Calcium magnesium | Active comparator | 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. Receives: Drug: Calcium and Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Secondary outcomes (4)
Cumulative dose of oxaliplatin and time of onset when the first PSN grade 2, 3 or 4 occurs
Measured: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Dose-reduction, dose-delay and discontinuation of oxaliplatin due to PSN grade 3 or 4
Measured: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Patient self-reported neurotoxicity scale for chronic peripheral neuropathy
Measured: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Progression Free Survival / PFS (for metastatic patients)
Measured: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087658
- Sponsor's protocol ID
- OXALI_L_03768
- Other IDs
- U1111-1116-9494
- Acronym
- GLUTOX
- Status last verified
- Jun 2013
- First submitted
- 15 Mar 2010
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01087658
- Acronym / sponsor ID
- GLUTOX / OXALI_L_03768
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine and calcium magnesium | Experimental | Drug: Glutamine, Drug: Calcium and MagnesiumGlutamine 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. |
| Calcium magnesium | Active comparator | Drug: Calcium and Magnesium1g 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically- or cytologically- proven adenocarcinoma of the colon or rectum.
- Disease either in adjuvant or 1st line metastatic setting.
- Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2.
- At least 4 weeks following any major surgical procedure(s) and recovery from any surgical sequelae.
- Electrocardiogram (ECG) with no acute or recent changes within limit of normal range, and not presenting abnormalities contraindicating the proposed chemotherapy.
Key exclusion criteria (15 listed)
- 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.
- Previous oxaliplatin-based chemotherapy.
- Previous or current diagnosis of PSN.
- 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).
- History of known allergy to oxaliplatin or other platinum agents, 5-FU, LV or capecitabine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutaminePer os | Drug | Glutamine and calcium magnesium |
| Calcium and MagnesiumIntravenous | Drug | Calcium magnesium, Glutamine and calcium magnesium |
Primary outcome
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
4 secondary outcomes
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
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
Patient self-reported neurotoxicity scale for chronic peripheral neuropathy
Time frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Progression Free Survival / PFS (for metastatic patients)
Time frame: Every cycle i.e. 2 or 3 weeks according to the treatment arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glutamine and Calcium and Magnesium in people with Colorectal Neoplasms, run by Sanofi at 14 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.