OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma (OXIRI)
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|ClinicalTrials.gov Identifier: NCT02368860|
Recruitment Status : Recruiting
First Posted : February 23, 2015
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: oxaliplatin, irinotecan, capecitabine||Phase 1|
This study comprises a dose escalation phase using 3+3 design to determine the safety, tolerability and pharmacokinetics of the OXIRI regimen and an expansion phase to further evaluate the MTD and to determine early signs of efficacy.
Eligible patients will receive a novel chemotherapeutic regimen (OXIRI regimen) with xeloda being administered in a chronomodulated fashion and the dose of irinotecan being guided by the UGT1A1*28 and UGT1A1*6 genotype status of the patient.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] Treatment in Patients With Advanced and/or Metastatic Pancreatic Adenocarcinoma|
|Study Start Date :||September 17, 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
OXIRI regimen: oxaliplatin, irinotecan, capecitabine
Drug: oxaliplatin, irinotecan, capecitabine
fixed doses of intravenous oxaliplatin 50 mg/m2, and intravenous irinotecan administered on days 1 and 8 in a 21 day-cycle while xeloda will be administered daily at around midnight from day 1 to day 14
Other Name: Eloxatin, Camptosar, CPT-11, Xeloda
- 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 [ Time Frame: from first dose to 30 days after last dose ]The safety and tolerability of the regimen will be assessed when the patient is on treatment and till 30 days after treatment.
- 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 [ Time Frame: 2 years ]
- Recommended Phase II dose (RP2D) of the OXIRI regimen which is the MTD [ Time Frame: 2 years ]
- Pharmacokinetics analysis of capecitabine [ Time Frame: cycle 1 day 1 ]Plasma level of capecitabine, its intermediary metabolites (5'-deoxy-5-fluorocytidine [DFCR] and 5'- deoxy-5- fluorouridine [DFUR]) and 5FU will be measured at multiple time points on C1D1
- Pharmacokinetics analysis of Irinotecan [ Time Frame: cycle 1 day 1 ]Plasma level of Irinotecan, SN-38 (active metabolite of irinotecan) and SN-38G will be measured at multiple time points on C1D1
- Efficacy of OXIRI as measured by response evaluation criteria in solid tumours (RECIST) version 1.1 [ Time Frame: 3 years ]
- Circulating tumour cells (CTCs) analysis [ Time Frame: at pre-treatment, Day 1 of each cycle and during response evaluation by imaging ]CTC characterization, and the changes of CTCs number and their relationship to changes in serum CA19-9 levels, tumour response on imaging etc. will be analysed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368860
|Contact: Yvonne Changfirstname.lastname@example.org|
|Contact: Matthew CH Ng, Dremail@example.com|
|National Cancer Centre||Recruiting|
|Singapore, Singapore, 169610|
|Contact: Lanying Wang 64368267 firstname.lastname@example.org|
|Principal Investigator:||Matthew CH Ng, Dr||National Cancer Centre, Singapore|