Clinical trial · Interventional
A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
A Phase I and Pharmacokinetic Study of S-1 Combined With Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
NCT00506207CI-TRIAL-00000803TIROXunknownPhase 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 is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastric Neoplasm | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1, Irinotecan, Oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Toxicity measured by NCICTC v.3
- timeFrame
- During treatment
- measure
- Blood level of irinotecan and S-1 and their metabolites
- timeFrame
- At 1st cycle
Secondary outcomes (1)
- measure
- Maximal response rate, progression-free survival, survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Measurable disease, according to the RECIST criteria or non-measurable disease Measurable lesions * Previous adjuvant, palliative chemotherapy including 5-FU, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed * Adequate major organ functions * Patients should sign a written informed consent before study entry Exclusion Criteria: * Prior history of peripheral neuropathy * Inadequate cardiovascular * Serious concurrent infection or nonmalignant illness * Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix * Psychiatric disorder that would preclude compliance * Pregnant, nursing women or patients with reproductive potential without contraception * Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
References
Publications (0)
Data not yet available
No reference posted for this study.