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

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont Medical Center
Study ID
NCT06648785
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • GI Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin — DRUG
    85 mg/m2 oxaliplatin
  • Fluoropyrimidine — DRUG
    oral fluoropyrimidine 1000mg/m2

Study Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Tolerability [ Time Frame: 115 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of VermontBurlingtonVermont05401-
University of Vermont Medical CenterBurlingtonVermont05401-

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By research site
University of Vermont· Burlington, VTUniversity of Vermont Medical Center· Burlington, VT

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