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Alkylating agent
Extended-duration Oxaliplatin Infusion for Gastrointestinal Cancer
Phase 2
Recruiting
Led By Olumide B. Gbolahan, MBBS, MSc
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absolute neutrophil count (ANC) ≥ 1,500/µL (no white blood cell growth factors allowed to meet requirement)
Confirmed diagnosis of a gastrointestinal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin
Awards & highlights
Study Summary
This trial is testing if giving the chemotherapy drug oxaliplatin over 6 hours, instead of the usual 2 hours, can help prevent nerve damage.
Who is the study for?
This trial is for adults with gastrointestinal cancers planning to undergo at least 4 cycles of FOLFOX6 chemotherapy. They must have a confirmed diagnosis, measurable disease, and be in good enough health to participate (ECOG status 0-2). Participants need normal blood counts and organ function, and women who can become pregnant must use effective birth control.Check my eligibility
What is being tested?
The study is testing if giving the drug Oxaliplatin over a longer period (6 hours) reduces nerve damage compared to standard infusion times. This could help patients maintain their regular chemotherapy doses without delays due to side effects.See study design
What are the potential side effects?
Oxaliplatin may cause side effects like nerve damage which can lead to numbness or tingling in hands and feet. Other possible side effects include allergic reactions, fatigue, digestive issues such as nausea or diarrhea, low blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without medication.
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I have been diagnosed with cancer in my digestive system.
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I am scheduled for 4 or more cycles of FOLFOX6 chemotherapy.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of 2 versus 6-hour oxaliplatin infusion time on neuropathy as measured by patient reported outcome (PRO) scores on the European Organization for Research and Treatment of Cancer (EORTC) chemotherapy-induced peripheral neuropathy (CIPN-20) scale
Secondary outcome measures
Changes in tumor size
Dose density
Duration of therapy
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 6-hour infusion groupExperimental Treatment3 Interventions
Patients receive oxaliplatin IV over 6 hours on day 1. Patients also receive leucovorin and fluorouracil as in the 2-hour infusion group. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Group II: 2-hour infusion groupActive Control3 Interventions
Patients receive oxaliplatin IV and leucovorin IV over 2 hours on day 1. Patients also receive a lower dose of fluorouracil IV over 2-4 minutes followed by a higher dose IV continuous over 4-6 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
Fluorouracil
2014
Completed Phase 3
~11540
Oxaliplatin
2011
Completed Phase 4
~2560
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,586 Total Patients Enrolled
University of PittsburghOTHER
1,722 Previous Clinical Trials
16,342,876 Total Patients Enrolled
Hematology/Oncology Pharmacy AssociationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe infections or serious liver conditions.I do not have severe heart problems like recent heart attacks or uncontrolled heart failure.I haven't had cancer treatment in the last 2 weeks.My white blood cell count is healthy without medication.I have never needed 4 or more blood transfusions in 2 days due to severe bleeding.My cancer is confirmed and measurable or can be evaluated.My kidneys are functioning well enough for treatment.I have been diagnosed with cancer in my digestive system.You have experienced bad reactions or allergies to any of the medications used in the FOLFOX6 treatment.I am using effective birth control or am not able to become pregnant.My hemoglobin level is at least 8 g/dL, possibly after a recent transfusion.I am scheduled for 4 or more cycles of FOLFOX6 chemotherapy.I have moderate to severe nerve damage in my hands or feet.I am able to get out of my bed or chair and move around.My platelet count is at least 75,000/µL, transfusions included.
Research Study Groups:
This trial has the following groups:- Group 1: 2-hour infusion group
- Group 2: 6-hour infusion group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most common indications for prescribing Oxaliplatin?
"Oxaliplatin is a common treatment for advanced esophageal cancers, but can also be used to manage folate, stage iii colon cancer, and advanced gastric cancer."
Answered by AI
Are recruitment efforts for this clinical trial ongoing at this time?
"That is accurate. According to the information available on clinicaltrials.gov, this study is still looking for patients. The posting date was March 14th, 2019 and the most recent update was on June 22nd, 2022. They need a total of 60 people from 3 different locations."
Answered by AI
What is the official stance of the FDA on Oxaliplatin?
"While there is some data supporting Oxaliplatin's safety, it remains unproven whether or not the medication is effective. Consequently, it received a score of 2."
Answered by AI
What is the history of medical research involving Oxaliplatin?
"Currently, there are 564 active clinical trials for the medication Oxaliplatin with 194 of them being in Phase 3. A large percentage of these studies are taking place in Guangzhou, Guangdong; however, overall there are 25836 locations running clinical trials that involve this drug."
Answered by AI
How many human subjects are participating in this clinical research?
"Yes, the research team is currently enrolling patients for this study. The trial was first posted on clinicaltrials.gov on 3/14/2019 and has been updated as recently as 6/22/2022. They are looking to recruit 60 individuals from 3 hospitals or clinics."
Answered by AI
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