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

Sponsor: University of Vermont Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06648785

This feasibility study evaluates the tolerability and toxicity of a modified capecitabine and oxaliplatin regimen in patients with GI malignancies. Eligible participants are those undergoing non-curative CAPOX or FOLFOX treatment for over three months. The intervention includes 85 mg/m2 oxaliplatin and 1000 mg/m2 oral fluoropyrimidine, with allowance for additional anti-cancer medications.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
University of Vermont Medical Center05401BurlingtonVermont
University of Vermont05401BurlingtonVermont

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