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

Phase 2

• Conditions: GI Cancers
• Interventions: Drug: oxaliplatin; Drug: Fluoropyrimidine

• Registration Number: NCT06648785
• Lead Sponsor: University of Vermont Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Study Start: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified administration schedule of capecitabine with oxaliplatin	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.
Modified administration schedule of capecitabine with oxaliplatin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States