Clinical trial · Interventional
Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies
NCT06648785CI-TRIAL-00102474enrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GI Cancers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoropyrimidine | Drug | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified administration schedule of capecitabine with oxaliplatin
- 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.
- interventionNames
- Drug: oxaliplatin
- Drug: Fluoropyrimidine
Primary outcomes (4)
- measure
- Tolerability
- timeFrame
- 115 days
- description
- Number of toxicity-related treatment delays Number of dose reductions
- measure
- Toxicity
- timeFrame
- 115 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.