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Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer.
This study is currently recruiting participants.
Verified by Hokkaido Gastrointestinal Cancer Study Group, October 2007
Sponsors and Collaborators: Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Information provided by: Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00209729
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: Taxotere
Drug: TS-1
Phase I
Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Docetaxel S 1 (Combination)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Study of Oral S-1 Plus Docetaxel in Elderly Patients With Advanced Gastric Cancer

Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

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

Estimated Enrollment: 50
Study Start Date: April 2005
Estimated Study Completion Date: March 2010
Arms Assigned Interventions
1: Experimental
Docetaxel plus S-1
Drug: Taxotere
X mg/m2, IV (in the vein) on day 1 and 15 of each 28 day cycle.
Drug: TS-1
Day 1-14, P.O. everyday

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.

  Eligibility

Ages Eligible for Study:   76 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209729

Contacts
Contact: Yoshito Komatsu, MD, PhD +81-11-716-1161 ykomatsu@med.hokudai.ac.jp
Contact: Satoshi Yuki, MD +81-11-716-1161 satoshi-yuuki175@joy.ocn.ne.jp

Locations
Japan, Hokkaido
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine) Recruiting
Sapporo, Hokkaido, Japan, 060-8638
Contact: Yoshito Komatsu, MD, PhD     +81-11-716-1161     ykomatsu@med.hokudai.ac.jp    
Contact: Satoshi Yuki, MD     +81-11-716-1161     satoshi-yuuki175@joy.ocn.ne.jp    
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Investigators
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

Study ID Numbers: HGCSG0502, DS-Elderly
Study First Received: September 13, 2005
Last Updated: October 31, 2007
ClinicalTrials.gov Identifier: NCT00209729  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
Docetaxel
S-1
Elderly Patients
Gastric cancer

Study placed in the following topic categories:
Docetaxel
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009