S-1 Combination Therapy in Esophagogastric Cancer Patients
Research type
Research Study
Full title
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, DOSE-FINDING, SAFETY AND TOLERABILITY STUDY OF ORALLY ADMINISTERED TEYSUNO (S-1) IN COMBINATION WITH EPIRUBICIN AND OXALIPLATIN IN PATIENTS WITH ADVANCED SOLID TUMORS: PART 2 - ESOPHAGOGASTRIC CANCER
IRAS ID
133742
Contact name
Abdul Wasat Mansoor
Contact email
Sponsor organisation
Disphar International B.V.
Eudract number
2011-003471-11
Research summary
Aim of the ’part 2’ section of this Phase 1 study is to investigate safety and determine the maximum tolerated dose (MTD) of S-1 (25 mg/m2 or 20 mg/m2) when combined with epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 (EOS triplet) in patients with advanced or metastatic esophagogastric cancer in first line treatment.
MTD is defined as the highest dose level at which less than 33% of the patients experience a dose-limiting toxicity (DLT) during Cycle 1. The standard 3-weekly dosing of oxaliplatin and epirubicin will be administered with S-1. It is possible that the MTD in patients receiving the EOS triplet as first line treatment for advanced or metastatic esophagogastric cancer may potentially be higher. Therefore, further evaluation and safety assessment of the 25 mg/m2/dose BID S-1 regimen in combination therapy is intended in a cohort of patients such as that featured in this protocol.
This trial contains 2 phases, the treatment cycle in both phases of the trial will last 21days:
• The first (tolerability) phase will establish tolerability of the dosing regimen and will last approximately 3 weeks.
• The second (extension) phase allows patients to continue treatment after they have completed the first phase.Each treatment cycle is 3 weeks. S-l will be administered orally BID on Days 1-15, with the first dose administered in the evening of Day 1 of each cycle and the last dose administered in the morning of Day 15, followed by a recovery period from Day 15 - Day 2l. On Day 1 of each 3-week cycle, oxaliplatin 130mg/m2 will be administered as a 2-hour IV infusion and epirubicin 50 mg/m2 will be administered as an IV bolus injection.
Tumour assessments will be performed throughout the study and analyzed using Response Evaluation Criteria in Solid Tumors (RECIST). CT scans will be performed at the end of every 3 cycles.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0569
Date of REC Opinion
11 Oct 2013
REC opinion
Further Information Favourable Opinion