- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01157039
A Trial of Glutamine to Prevent Oxaliplatin Neurotoxicity and a Pharmacokinetic Analysis of Oxaliplatin
February 23, 2016 updated by: AHS Cancer Control Alberta
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Post cycle 2 and cycle 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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.
|
Post cycle 2 to 30-day follow-up visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Michael Sawyer, MD, Alberta Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
September 1, 2012
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
July 2, 2010
First Submitted That Met QC Criteria
July 2, 2010
First Posted (Estimate)
July 5, 2010
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Poisoning
- Colorectal Neoplasms
- Neurotoxicity Syndromes
Other Study ID Numbers
- 25070
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on Glutamine
-
University of AlbertaCompleted
-
Southwest Oncology GroupNational Cancer Institute (NCI)TerminatedPain | Head and Neck Cancer | Cancer-related Problem/ConditionCanada, United States
-
Emmaus Medical, Inc.Completed
-
Daren K. HeylandCanadian Institutes of Health Research (CIHR)Active, not recruitingBurnsUnited States, Belgium, Canada, Singapore, Spain, Austria, Brazil, Dominican Republic, Germany, Italy, Paraguay, Sweden, Thailand, United Kingdom
-
Eastern Regional Medical CenterTSPC America, Inc.WithdrawnPeripheral NeuropathyUnited States
-
Banaras Hindu UniversityCompleted
-
Hawaii Pacific HealthUnknown
-
Tulane UniversityCompletedDiarrhea-Predominant Irritable Bowel SyndromeUnited States
-
University of VirginiaImperial College LondonRecruitingClostridium Difficile Infection | Clostridium Difficile Diarrhea | Clostridioides Difficile Infection | Clostridia Difficile ColitisUnited States
-
University of Missouri, Kansas CityUnited States Department of DefenseCompletedHemorrhagic ShockUnited States