GI CancersPhase 2NCT06648785
Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies
A Phase 2 study testing oxaliplatin and Fluoropyrimidine in people with GI Cancers, run by University of Vermont Medical Center at 2 sites in United States.
Trial summary
This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Cancers
- What is being tested?
- oxaliplatin and Fluoropyrimidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2024to Nov 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
- Patient with GI malignancy
- Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for >3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.
Who cannot join
- Patients not meeting standard hematologic parameters for chemotherapy administration as follows:
- Absolute neutrophil count (ANC) ≥ 1500
- Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows:
- AST ≤ 5x ULN
- ALT ≤ 5X ULN
- Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows:
- Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont
Burlington, Vermont, 05401
About this study
This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.
- Conditions
- GI Cancers
- Being tested
- oxaliplatin, Fluoropyrimidine
- Keywords
- capecitabine, oxaliplatin, GI, chemotherapy, fluoropyrimidine, modified schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
85 mg/m2 oxaliplatin
FluoropyrimidineDrug
oral fluoropyrimidine 1000mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Modified administration schedule of capecitabine with oxaliplatin | Experimental | * Oxaliplatin (85mg/m2), will be administered IV every 2 weeks
* Capecitabine (1000mg/m2) will be given twice daily, administered orally (PO) for 7 days, followed by 7 days with no capecitabine Cycles will repeat every 14 days. Receives: Drug: oxaliplatin; Drug: Fluoropyrimidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Number of toxicity-related treatment delays Number of dose reductions
Measured: 115 days
Toxicity
Severity of acute oxaliplatin reactions, graded 1-4
Measured: 115 days
Neuropathy
Neuropathy will be graded 1-4 after 2 \&4 months of severity
Measured: 2-4 months after therapy
Cytopenias
Frequency of cytopenia grade 3 or higher.
Measured: 115 days
Secondary outcomes (1)
Tumor response
Response rate after 3-4 months, with exact time of restaging per investigator choice and investigator usual practice
Measured: 115 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start21 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI CancersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot/feasibility design with tolerability and toxicity as primary endpoints and response as exploratory endpoint. Standard drug dosages utilized with no dose finding component to this study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall F Holcombe, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648785
- Sponsor's protocol ID
- STUDY00003100/UVMCC2404
- Status last verified
- Feb 2026
- First submitted
- 14 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies
- ClinicalTrials.gov ID
- NCT06648785
- Acronym / sponsor ID
- STUDY00003100/UVMCC2404
- Conditions
- GI Cancers
- Keywords
- capecitabine, oxaliplatin, GI, chemotherapy, fluoropyrimidine, modified schedule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Oct 2024 (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 study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot/feasibility design with tolerability and toxicity as primary endpoints and response as exploratory endpoint. Standard drug dosages utilized with no dose finding component to this study.
| Arm | Type | Receives |
|---|---|---|
| Modified administration schedule of capecitabine with oxaliplatin | Experimental | Drug: oxaliplatin, Drug: Fluoropyrimidine* Oxaliplatin (85mg/m2), will be administered IV every 2 weeks * Capecitabine (1000mg/m2) will be given twice daily, administered orally (PO) for 7 days, followed by 7 days with no capecitabine Cycles will repeat every 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with GI malignancy
- Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for >3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.
Key exclusion criteria (7 listed)
- Patients not meeting standard hematologic parameters for chemotherapy administration as follows:
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 |
|---|---|---|
| oxaliplatin85 mg/m2 oxaliplatin | Drug | Modified administration schedule of capecitabine with oxaliplatin |
| Fluoropyrimidineoral fluoropyrimidine 1000mg/m2 | Drug | Modified administration schedule of capecitabine with oxaliplatin |
Primary outcome
Tolerability
Time frame: 115 days
Number of toxicity-related treatment delays Number of dose reductions
Toxicity
Time frame: 115 days
Severity of acute oxaliplatin reactions, graded 1-4
Neuropathy
Time frame: 2-4 months after therapy
Neuropathy will be graded 1-4 after 2 \&4 months of severity
Cytopenias
Time frame: 115 days
Frequency of cytopenia grade 3 or higher.
1 secondary outcome
Tumor response
Time frame: 115 days
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 5 Feb 2026.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 oxaliplatin and Fluoropyrimidine in people with GI Cancers, run by University of Vermont Medical Center at 2 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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Tolerability (time frame: 115 days). The study lists 4 primary outcomes in all. 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 5 Feb 2026.