Malignant Digestive System NeoplasmPhase 2NCT03800693
2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers
A Phase 2 study testing Fluorouracil, Leucovorin and Oxaliplatin in people with Malignant Digestive System Neoplasm, run by Emory University at 3 sites in United States.
Trial summary
This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Digestive System Neoplasm
- What is being tested?
- Fluorouracil, Leucovorin and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Mar 2019to 17 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Confirmed diagnosis of a gastrointestinal cancer
- Plan for 4 or more cycles of FOLFOX6 (fluorouracil [with leucovorin] and oxaliplatin) containing chemotherapy
- Histologically confirmed, measurable or evaluable disease. Patients with advanced or metastatic disease should have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients in the adjuvant treatment setting planned to have > 4 cycles of FOLFOX-containing chemotherapy are eligible and will be followed per standard of care
- Absolute neutrophil count (ANC) ≥ 1,500/µL (no white blood cell growth factors allowed to meet requirement)
- Platelets ≥ 75,000/µL (may be transfused up to 72 hours prior to day 1 to meet requirement)
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- Hemoglobin ≥ 8 g/dL (may be transfused up to 72 hours prior to day 1 to meet requirement)
- Creatinine clearance > 30 mL/min by Cockcroft-Gault, to preserve similar dosing (85 mg/m²) for analysis
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Signed informed consent
- Adequate birth control when appropriate
Who cannot join
- Any preexisting grade 2 or higher peripheral neuropathy
- Patients currently receiving anticancer therapies or who have received any focal or systemic anticancer therapy within 14days of the start of FOLFOX6
- Known intolerance or hypersensitivity to any agent in FOLFOX6 or concurrent agents
- Patients who have any known severe and/or uncontrolled medical conditions such as:
- Unstable angina pectoris, symptomatic heart failure; (New York Heart Association class III or IV), myocardial infarction ≤ 6 months prior, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
- Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, or decompensated liver disease
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- Patients with any history of severe hemorrhage requiring ≥ 4 units of packed red blood cells (RBCs) in a 48-hour period
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
- Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 14days prior to dosing
- Pregnant or nursing (lactating) women
- Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:
- Use of oral, injected or implanted hormonal methods of contraception or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
- Total abstinence or;
- Male/female sterilization Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amber Draper, PharmD contact
United States3 sites, 3 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Autumn Lunceford, 404-686-1638, patricia.autumn.lee.lunceford@emory.edu
Olumide B. Gbolahan, MBBS, MSc
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Allyson Anderson, 404-686-0239, allyson.anderson@emory.edu
Olumide B. Gbolahan, MBBS, MSc
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Alicia Escobar, 678-843-7029, alicia.m.escobar@emory.edu
Olumide B. Gbolahan, MBBS, MSc
About this study
Official title: Phase II Evaluation of the Effect of 2 Versus 6 Hour Oxaliplatin Infusions on Neuropathy and Pharmacokinetics in Patients With Gastrointestinal Cancers
This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effect of 2 versus 6-hour oxaliplatin infusion time on the difference in severity of sensory 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 at the initiation of cycle 4.
SECONDARY OBJECTIVES:
- Pharmacokinetic parameters of maximum concentration (Cmax), area under the curve (AUC), time of maximum concentration (tmax), clearance, and half life (t1/2) of platinum ultra-filtrate.
II. CIPN-20 sensory score changes over the duration of therapy as measured by a cumulative area-under-the curve score.
III. Clinical outcomes including duration of therapy, oxaliplatin dose reductions, delays in therapy, and overall dose intensity and delivery of oxaliplatin.
IV. Relationship between oxaliplatin Cmax, patient-reported acute neurotoxicity, and chronic neurotoxicity by CIPN-20 scores.
OUTLINE: Patients are randomized to 1 of 2 groups.
2-hour infusion group: Patients receive oxaliplatin intravenously (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.
6-hour infusion group: 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.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 18 months.
- Conditions
- Malignant Digestive System Neoplasm
- Being tested
- Fluorouracil, Leucovorin, Oxaliplatin
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Also called 5-FU, Carac, Ribofluor
Given IV
LeucovorinDrug
Also called Folinic acid
Given IV
OxaliplatinDrug
Also called Eloxatin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 2-hour infusion group | Active comparator | 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. Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin |
| 6-hour infusion group | Experimental | 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. Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The EORTC-CIPN-20 sub-scales will be computed according to the standard scoring algorithm and then transformed to a 0 to 100 scale, where high scores mean less symptom burden. The primary outcome measure of difference in sensory scores of the two groups between baseline and the initiation of cycle 4 will be the driver of the analysis.
Measured: Baseline up to 60 days (course 4)
Secondary outcomes (5)
Maximum concentrations achieved (Cmax)
The study will focus on maximum concentrations achieved (Cmax) with each infusion time. Data will be analyzed using non-compartmental methods via Phoenix WinNonlin analytical software, version 8.0 or higher.
Measured: At baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin
Changes in tumor size
The study will assess changes in tumor size per standard of care assessments at screening and every 2 months.
Measured: Up to 18 months after completion or discontinuation of chemotherapy
Duration of therapy
Duration of therapy will be recorded.
Measured: Up to 18 months after completion or discontinuation of chemotherapy
Dose density
Dose density will be recorded.
Measured: Up to 18 months after completion or discontinuation of chemotherapy
Frequency of dose holds or reductions
Frequency of dose holds or reductions will be recorded.
Measured: Up to 18 months after completion or discontinuation of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Mar 2019
- Primary completion5 Aug 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Digestive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Hematology/Oncology Pharmacy Association, University of Pittsburgh
- Responsible party
- Principal investigator, Olumide Gbolahan, Emory University
- Investigators
- Olumide B. Gbolahan, MBBS, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800693
- Sponsor's protocol ID
- IRB00106610
- Other IDs
- NCI-2018-02241, Winship4468-18
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2019
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of the Effect of 2 Versus 6 Hour Oxaliplatin Infusions on Neuropathy and Pharmacokinetics in Patients With Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT03800693
- Acronym / sponsor ID
- IRB00106610
- Conditions
- Malignant Digestive System Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Hematology/Oncology Pharmacy Association, University of Pittsburgh
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 11 Jan 2019 (actual)
- 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.
This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.
Detailed description
PRIMARY OBJECTIVE:
- To determine the effect of 2 versus 6-hour oxaliplatin infusion time on the difference in severity of sensory 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 at the initiation of cycle 4.
SECONDARY OBJECTIVES:
- Pharmacokinetic parameters of maximum concentration (Cmax), area under the curve (AUC), time of maximum concentration (tmax), clearance, and half life (t1/2) of platinum ultra-filtrate.
II. CIPN-20 sensory score changes over the duration of therapy as measured by a cumulative area-under-the curve score.
III. Clinical outcomes including duration of therapy, oxaliplatin dose reductions, delays in therapy, and overall dose intensity and delivery of oxaliplatin.
IV. Relationship between oxaliplatin Cmax, patient-reported acute neurotoxicity, and chronic neurotoxicity by CIPN-20 scores.
OUTLINE: Patients are randomized to 1 of 2 groups.
2-hour infusion group: Patients receive oxaliplatin intravenously (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.
6-hour infusion group: 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.
After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-hour infusion group | Active comparator | Drug: Fluorouracil, Drug: Leucovorin, Drug: OxaliplatinPatients 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. |
| 6-hour infusion group | Experimental | Drug: Fluorouracil, Drug: Leucovorin, Drug: OxaliplatinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Confirmed diagnosis of a gastrointestinal cancer
- Plan for 4 or more cycles of FOLFOX6 (fluorouracil [with leucovorin] and oxaliplatin) containing chemotherapy
- Histologically confirmed, measurable or evaluable disease. Patients with advanced or metastatic disease should have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients in the adjuvant treatment setting planned to have > 4 cycles of FOLFOX-containing chemotherapy are eligible and will be followed per standard of care
- Absolute neutrophil count (ANC) ≥ 1,500/µL (no white blood cell growth factors allowed to meet requirement)
Key exclusion criteria (16 listed)
- Any preexisting grade 2 or higher peripheral neuropathy
- Patients currently receiving anticancer therapies or who have received any focal or systemic anticancer therapy within 14days of the start of FOLFOX6
- Known intolerance or hypersensitivity to any agent in FOLFOX6 or concurrent agents
- Patients who have any known severe and/or uncontrolled medical conditions such as:
- Patients with any history of severe hemorrhage requiring ≥ 4 units of packed red blood cells (RBCs) in a 48-hour period
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 |
|---|---|---|
| FluorouracilAlso: 5-FU, Carac, RibofluorGiven IV | Drug | 2-hour infusion group, 6-hour infusion group |
| LeucovorinAlso: Folinic acidGiven IV | Drug | 2-hour infusion group, 6-hour infusion group |
| OxaliplatinAlso: EloxatinGiven IV | Drug | 2-hour infusion group, 6-hour infusion group |
Primary outcome
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
Time frame: Baseline up to 60 days (course 4)
The EORTC-CIPN-20 sub-scales will be computed according to the standard scoring algorithm and then transformed to a 0 to 100 scale, where high scores mean less symptom burden. The primary outcome measure of difference in sensory scores of the two groups between baseline and the initiation of cycle 4 will be the driver of the analysis.
5 secondary outcomes
Maximum concentrations achieved (Cmax)
Time frame: At baseline and at 1, 2, 4, 6, 48, and 192 hours after initiation of oxaliplatin
Changes in tumor size
Time frame: Up to 18 months after completion or discontinuation of chemotherapy
Duration of therapy
Time frame: Up to 18 months after completion or discontinuation of chemotherapy
Dose density
Time frame: Up to 18 months after completion or discontinuation of chemotherapy
Frequency of dose holds or reductions
Time frame: Up to 18 months after completion or discontinuation of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Amber Draper, PharmD contact
Olumide B. Gbolahan, MBBS, MSc principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorouracil, Leucovorin and Oxaliplatin in people with Malignant Digestive System Neoplasm, run by Emory University at 3 sites in United States.
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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olumide B. Gbolahan, MBBS, MSc (404-778-0032, ogbolah@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline up to 60 days (course 4)). 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 6 Nov 2025.