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

University of Vermont Medical Center

Status and phase: Invitation-only; Phase 2

Conditions: GI Cancers

Treatments: Drug: Fluoropyrimidine; Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06648785

STUDY00003100/UVMCC2404

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Modified administration schedule of capecitabine with oxaliplatin

Experimental group

Description:

* 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.

Treatment:

Drug: oxaliplatin

Drug: Fluoropyrimidine