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Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers

Phase 1
18 Years
Open (Enrolling)
Gastrointestinal Neoplasms

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Trial Information

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
safety profile.

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.

Inclusion Criteria:

- Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal

- Minimum age of 18 years

- ECOG Performance status 0-2

- Life expectancy >3 months

- Presence of measurable or evaluable disease by RECIST

- Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if
more than 4 weeks elapsed since completion of chemotherapy.

- More than 4 weeks since completion of prior radiotherapy (measurable or evaluable
lesions should be outside the radiation field)

- Adequate organ functions

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

- Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant

- Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.

- Patients with active infection, severe heart disease, uncontrollable hypertension or
diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or
breast feeding

- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ
cancer of uterine cervix

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Dae Young Zang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hallym University Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

December 2012

Related Keywords:

  • Gastrointestinal Neoplasms
  • Gastrointestinal neoplasms
  • Oxaliplatin
  • Irinotecan
  • S-1
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms