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

Phase 1/Phase 2
76 Years
80 Years
Not Enrolling
Gastric Cancer

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

April 2005

Completion Date:

March 2010

Related Keywords:

  • Gastric Cancer
  • Docetaxel
  • S-1
  • Elderly Patients
  • Gastric cancer
  • Stomach Neoplasms