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

Status

Suspended

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209729

Enrollment

Registered

2005-09-21

Start date

2005-04-30

Completion date

2010-03-31

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Docetaxel, S-1, Elderly Patients, Gastric cancer

Brief summary

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

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.

Interventions

DRUGTaxotere

X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.

DRUGTS-1

Day 1-14, P.O. everyday

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

76 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026