NCT00209729

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 gastric-cancer

Timeline
Completed

Started Apr 2005

Typical duration for phase_1 gastric-cancer

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 26, 2010

Status Verified

May 1, 2010

Enrollment Period

4.7 years

First QC Date

September 13, 2005

Last Update Submit

May 24, 2010

Conditions

Gastric Cancer

Keywords

DocetaxelS-1Elderly PatientsGastric cancer

Outcome Measures

Primary Outcomes (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.

    1-year

Secondary Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Docetaxel plus S-1

Drug: TaxotereDrug: TS-1

Interventions

TaxotereDRUG

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

Also known as: Docetaxel
1
TS-1DRUG

Day 1-14, P.O. everyday

Also known as: S-1
1

Eligibility Criteria

Age76 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histological diagnosis of gastric adenocarcinoma.
  • Measurable or assessable lesions(Except for Phase I).
  • Age: 76 \~ 80 years.
  • Performance Status (ECOG): 0 \~ 2.
  • 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.
  • No history of treatment with Docetaxel or S-1.
  • No history of radiotherapy to the abdomen.
  • Oral intake of S-1 is possible.
  • 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).
  • Predicted survival for \>3 months.
  • Able to give written informed consent.

You may not qualify if:

  • Severe pleural effusion or ascites.
  • Metastasis to the central nervous system (CNS).
  • Active gastrointestinal bleeding.
  • Active infection.
  • Diarrhea (watery stools).
  • Uncontrolled ischemic heart disease.
  • Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  • Active multiple cancer.
  • Severe mental disorder.
  • Pregnancy, possible pregnancy, or breast-feeding.
  • Flucytosine treatment.
  • Judged to be ineligible for this protocol by the attending physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxeltitanium silicideS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Masahiro Asaka, MD, PhD

    Hokkaido Gastrointestinal Cancer Study Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

May 26, 2010

Record last verified: 2010-05

Locations

JP(1)