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

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ClinicalTrials.gov Identifier: NCT00209729
Recruitment Status : Suspended (Registration is less)
First Posted : September 21, 2005
Last Update Posted : May 26, 2010
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Taxotere Drug: TS-1 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer
Study Start Date : April 2005
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Docetaxel plus S-1
Drug: Taxotere
X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
Other Name: Docetaxel
Drug: TS-1
Day 1-14, P.O. everyday
Other Name: S-1

Primary Outcome Measures :
  1. 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. [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Determine the clinical response rate of patients in Phase I setting. [ Time Frame: 1-year ]
  2. Determine the OS(Overall Survival) and DFS(Disease Free Survival). [ Time Frame: 2-years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   76 Years to 80 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209729

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group

Responsible Party: Yoshito Komatsu / A vice-director, Associate Prof., Hokkaido University Hospital Cancer Center
ClinicalTrials.gov Identifier: NCT00209729     History of Changes
Other Study ID Numbers: HGCSG0502
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: May 2010

Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
Elderly Patients
Gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action