Clinical trial · Interventional
S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer
Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers
NCT01693445CI-TRIAL-00020994completedPhase 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 study will attempt to determine the feasibility of combination of Oxaliplatin, Irinotecan, and S-1, 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.
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 |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OIS (Oxaliplatin, Irinotecan, S-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OIS (Oxaliplatin, Irinotecan, S-1)
- description
- Dose level 1 treatment will be delivered as a 2-week cycle as bellows; 1. Oxaliplatin 85 mg/m²IV on day 1 2. Irinotecan 120 mg/m² IV on day 1 3. S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.
- interventionNames
- Drug: OIS (Oxaliplatin, Irinotecan, S-1)
Primary outcomes (1)
- measure
- maximum tolerated dose
- timeFrame
- 6 months
Secondary outcomes (5)
- measure
- toxicity profiles
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract * 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 chemotherapy. * 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
References
Publications (0)
Data not yet available
No reference posted for this study.