Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers
Oxaliplatin or irinotecan has shown a considerable anti-tumor activity, when used in
combination with 5-fluorouracil (5-FU) in patients with gastrointestinal (GI) cancer.
Oxaliplatin, irinotecan, and 5-FU have different mechanisms of actions and do not share the
toxicity profiles. Since they have a synergistic effect, many clinical trials have been
conducted recently to evaluate the efficacy of triplet combination consisting of
oxaliplatin, irinotecan, and 5-FU, and demonstrated that the triple combination regimen was
effective and resulted in survival benefits with favorable toxicity profiles.
S-1 and capecitabine are novel oral fluoropyrimidines and different phase III trials have
shown that these oral agents are at least as active and effective as 5-FU with a superior
Biweekly triple combination of S-1 with oxaliplatin and irinotecan (OIS) is an interesting
alternative to increase convenience and to simply the treatment delivery.
In the present study, we attempt to determine the feasibility of OIS combination, the
maximum tolerated dose and the recommended doses of the agents used, and to preliminarily
evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
maximum tolerated dose
Dae Young Zang, MD, PhD
Hallym University Medical Center
Korea: Food and Drug Administration