Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies
Enrolling by invitation · Phase 2
Conditions studied: GI Cancers
In brief
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 facts
- Study ID
- NCT06648785
- Run by
- University of Vermont Medical Center
- People needed
- 20
- Starts
- 2024-10-21
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Vermont Medical Center — Burlington, Vermont, United States
- University of Vermont — Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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