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A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Stomach Neoplasms

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Trial Information

A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

Inclusion Criteria:

1. In phase I:histologically or cytologically confirmed advanced solid Cancer In phase
II:histologically or cytologically confirmed metastatic gastric adenocarcinoma

2. Age: over 18 years

3. No prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase
II portion Previous chemotherapy up to two regimens (including adjuvant
chemotherapy) is allowed in phase I portion; patients are required to have
discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks
before entry into phase I portion

4. Disease status must be that of measurable disease defined as: Lesions that can be
accurately measured in at least one dimension >10 mm with spiral CTscan and palpable
LN (including supraclavicular LN) in physical examination.

5. Performance status: ECOG 0-2

6. Adequate major organ function including the following Hematopoietic function:
WBC>4,000/mm3 or ANC> 2,000/mm3, Platelet count ³ 100,000/mm3Hepatic function:
Bilirubin UNL (Upper normal limit), AST/ALT levels 2.5X UNL Renal function:
Creatinine UNL

7. Patients should sign an informed consent

Exclusion Criteria:

1. Inadequate cardiovascular function: New York Heart Association class III or IV
heart disease Active angina or myocardial infarction within the past 6
monthsHistory of significant ventricular arrhythmia requiring medication with
antiarrhythmics or significantconduction system abnormality

2. Other malignancy within the past 3 years except nonmelanomatous skin cancer or
carcinoma in situ of the cervix

3. Pregnant or nursing women

4. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complications of study therapy

5. Psychiatric disorder that would preclude compliance

6. Patients receiving a concomitant treatment with drugs interacting with S-1 or
docetaxel: flucytosine, phenitoin, warfarin et al.

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:

*phase I study:the maximum tolerated doses (MTD)of S-1 and docetaxel,recommended dose for subsequent phase II study *phase II study: evaluation of efficacy and toxicities of this new combination regimen in metastatic

Outcome Time Frame:

During chemotherapy

Principal Investigator

Sook Ryun Park, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

August 2007

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • phase I/II
  • Combination chemotherapy
  • S-1
  • Docetaxel
  • Neoplasms
  • Carcinoma
  • Stomach Neoplasms