Clinical trial · Interventional
OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma
Phase I Trial of OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] Treatment in Patients With Advanced and/or Metastatic Pancreatic Adenocarcinoma
NCT02368860CI-TRIAL-00052030OXIRIcompletedPhase 1ClinicalTrials.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 is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen \[oxaliplatin (O), xeloda (X) and irinotecan (I)\] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda) administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid, fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin, irinotecan, capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OXIRI
- description
- OXIRI regimen: oxaliplatin, irinotecan, capecitabine
- interventionNames
- Drug: oxaliplatin, irinotecan, capecitabine
Primary outcomes (1)
- measure
- Safety and tolerability of the OXIRI regimen as measured by the frequency of significant adverse events incurred by the participants, using CTCAE ver. 4 grading system
- timeFrame
- from first dose to 30 days after last dose
- description
- The safety and tolerability of the regimen will be assessed when the patient is on treatment and till 30 days after treatment.
Secondary outcomes (5)
- measure
- Maximum tolerated dose (MTD) of capecitabine when administered in a continuous chronomodulated fashion with genotype-directed dosing of irinotecan and metronomic dosing of oxaliplatin, using a conventional 3+3 design
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients between 21 to 75 years of age
2. A histopathologically or cytological confirmed diagnosis of locally advanced and/or metastatic PDAC that is unresectable
3. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1 criteria
4. Life expectancy of at least 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
6. Adequate hematologic function (neutrophils count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L)
7. Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
8. Adequate renal function (calculated creatinine clearance \> 50 mL/min)
9. Able to give informed consent
10. Toxicity related to previous radiotherapy or chemotherapy resolved to ≤ Grade 1
Exclusion Criteria:
1. History of prior malignancy except non-melanoma skin cancer within the last 5yrs
2. Uncontrolled central nervous system (CNS) metastases or carcinomatous meningitis
3. Uncontrolled concomitant medical illnesses (e.g. hypertension, myocardial infarct, heart failure, ventricular arrhythmia, diabetes, severe infection)
4. Major surgery within four weeks prior to study treatment
5. Patients on chronic immunosuppressive therapy
6. Pregnant or breast-feeding female patients
7. On anticoagulant therapy with vitamin K antagonists.
8. Dose-escalation cohort:
* Patients homozygous for uridine diphosphate glucuronosyltransferase (UGT)1A1\*6/\*6 or UGT1A1\*28/\*28
* Previous oxaliplatin or irinotecan chemotherapy
* Treatment with any of the following anti-cancer therapies prior to the first dose of OXIRI within the stated timeframes
* Cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment. Exception for weekly chemotherapy regimens, where a minimum of 2 week washout from the last dose is required.
* Biological therapy (e.g., antibodies) within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug
* Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug
* Any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug
* Wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug
9. Dose-expansion cohort:
* Previous chemotherapy or radiotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.