Clinical trial · Interventional
Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.
Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer
NCT00209729CI-TRIAL-00003481suspendedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Registration is less
Summary
Brief summary (as posted)
To assess the usefulness of Docetaxel plus S-1 combination chemotherapy based on the antitumor effect and survival period by performing a phase I/II study of this combination in Elderly patients with inoperable or with postoperative gastric 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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Taxotere | Drug | Docetaxel | ALIAS |
| TS-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Docetaxel plus S-1
- interventionNames
- Drug: Taxotere
- Drug: TS-1
Primary outcomes (1)
- measure
- Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
- timeFrame
- 1-year
Secondary outcomes (2)
- measure
- Determine the clinical response rate of patients in Phase I setting.
- timeFrame
- 1-year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 76 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological diagnosis of gastric adenocarcinoma. 2. Measurable or assessable lesions(Except for Phase I). 3. Age: 76 \~ 80 years. 4. Performance Status (ECOG): 0 \~ 2. 5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy. 6. No history of treatment with Docetaxel or S-1. 7. No history of radiotherapy to the abdomen. 8. Oral intake of S-1 is possible. 9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). 10. Predicted survival for \>3 months. 11. Able to give written informed consent. Exclusion Criteria: 1. Severe pleural effusion or ascites. 2. Metastasis to the central nervous system (CNS). 3. Active gastrointestinal bleeding. 4. Active infection. 5. Diarrhea (watery stools). 6. Uncontrolled ischemic heart disease. 7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. Active multiple cancer. 9. Severe mental disorder. 10. Pregnancy, possible pregnancy, or breast-feeding. 11. Flucytosine treatment. 12. Judged to be ineligible for this protocol by the attending physician.
References
Publications (0)
Data not yet available
No reference posted for this study.