Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies (NCT06648785) | Clinical Trial Compass
By InvitationPhase 2
Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies
United States20 participantsStarted 2024-10-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.