Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.

Study Overview
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Brief Summary
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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.

Detailed Description
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A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on Elderly patients with histological stage IV gastric cancer given Docetaxel plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Official Title
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Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Taxotere
* Drug: TS-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of gastric adenocarcinoma. Measurable or assessable lesions(Except for Phase I). Age: 76   80 years. Performance Status (ECOG): 0   2. 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. No history of treatment with Docetaxel or S-1. No history of radiotherapy to the abdomen. Oral intake of S-1 is possible. 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). Predicted survival for >3 months. Able to give written informed consent. Exclusion Criteria: Severe pleural effusion or ascites. Metastasis to the central nervous system (CNS). Active gastrointestinal bleeding. Active infection. Diarrhea (watery stools). Uncontrolled ischemic heart disease. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). Active multiple cancer. Severe mental disorder. Pregnancy, possible pregnancy, or breast-feeding. Flucytosine treatment. Judged to be ineligible for this protocol by the attending physician.

Ages Eligible for Study
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Minimum Age: 76 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Docetaxel plus S-1 | Drug: Taxotere<br>* X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.<br>* Other names: Docetaxel;Drug: TS-1<br>* Day 1-14, P.O. everyday<br>* Other names: S-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the clinical response rate of patients in Phase I setting. |  | 1-year | 
| Determine the OS(Overall Survival) and DFS(Disease Free Survival). |  | 2-years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, Docetaxel, Elderly Patients, Gastric cancer