Colorectal CarcinomaPhase 2NCT01157039
A Trial of Glutamine to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin
A Phase 2 study testing Glutamine in people with Colorectal Carcinoma and Neoplasms, Colorectal, run by AHS Cancer Control Alberta.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Neoplasms, Colorectal, Colorectal Cancer
- What is being tested?
- Glutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 2
- 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
- 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.
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- 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
Who cannot join
- 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
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- 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.
About this study
Official title: A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.
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.
Read the 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.
- Conditions
- Colorectal Carcinoma, Neoplasms, Colorectal, Colorectal Cancer, Colorectal Tumors, Metastasis
- Being tested
- Glutamine
- Keywords
- glutamine, oxaliplatin, adverse effects
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Also called L-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).
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | 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 Receives: Dietary Supplement: Glutamine |
| Dietary supplement | Experimental | 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. Receives: Dietary Supplement: Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate potential pharmacokinetic interactions between oxaliplatin and glutamine at 30g and 40g in patients with metastatic colorectal cancer.
Measured: Post cycle 2 and cycle 3
Secondary outcomes (2)
To evaluate effects of glutamine supplementation on neuropathy and diarrhea related to oxaliplatin, and on dose reductions and in patients with metastatic colorectal cancer.
Measured: Post cycle 2 to 30-day follow-up visit
To compare the toxicity profile of glutamine and FOLFOX to historical data.
Measured: Post cycle 2 to 30-day follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startOct 2011
- Primary completionSep 2012 (estimated)
Why it stopped: abandoned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Michael Sawyer, MD, Study chair, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157039
- Sponsor's protocol ID
- 25070
- Status last verified
- Oct 2011
- First submitted
- 2 Jul 2010
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Glutamin to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin.
- ClinicalTrials.gov ID
- NCT01157039
- Acronym / sponsor ID
- 25070
- Conditions
- Colorectal Carcinoma, Neoplasms, Colorectal, Colorectal Cancer, Colorectal Tumors, Metastasis
- Keywords
- glutamine, oxaliplatin, adverse effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: abandoned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (estimated)
- First posted
- 5 Jul 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: GlutamineArm 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 | Experimental | Dietary Supplement: GlutamineArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| GlutamineAlso: L-glutamineGlutamine- 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). | Dietary supplement | Dietary Supplement, Dietary supplement |
Primary outcome
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
2 secondary outcomes
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
To compare the toxicity profile of glutamine and FOLFOX to historical data.
Time frame: Post cycle 2 to 30-day follow-up visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Michael Sawyer, MD study chair
Alberta Health services
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glutamine in people with Colorectal Carcinoma and Neoplasms, Colorectal, run by AHS Cancer Control Alberta.
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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
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). 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 24 Feb 2016.