Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies

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 Overview

• Status: Enrolling by invitation
• Conditions: GI Cancers
• Intervention / Treatment: Drug: oxaliplatin; Drug: Fluoropyrimidine

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
    • Burlington, Vermont, United States, 05401
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified administration schedule of capecitabine with oxaliplatin; 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.	Drug: oxaliplatin; 85 mg/m2 oxaliplatin; Drug: Fluoropyrimidine; oral fluoropyrimidine 1000mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability	Number of toxicity-related treatment delays Number of dose reductions	115 days
Toxicity	Severity of acute oxaliplatin reactions, graded 1-4	115 days
Neuropathy	Neuropathy will be graded 1-4 after 2 &4 months of severity	2-4 months after therapy
Cytopenias	Frequency of cytopenia grade 3 or higher.	115 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response	Response rate after 3-4 months, with exact time of restaging per investigator choice and investigator usual practice	115 days

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: capecitabine; chemotherapy; oxaliplatin; GI; fluoropyrimidine; modified schedule
• Additional Relevant MeSH Terms: Neoplasms; Organic Chemicals; Coordination Complexes; Oxaliplatin
• Other Study ID Numbers: STUDY00003100/UVMCC2404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes