NCT00270543

Brief Summary

The primary endpoint of this phase II trial is the objective tumor response rate. The secondary endpoints include treatment-related toxicity, the clinical benefit response defined by the change in performance status and body weight, the change in quality of life, progression free survival and overall survival. Simon's optimal two-stage design will be used to determine the patient number.

Trial Health

55
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Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
Last Updated

February 9, 2009

Status Verified

September 1, 2004

First QC Date

December 26, 2005

Last Update Submit

February 6, 2009

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasms

Outcome Measures

Primary Outcomes (2)

  • The primary objective is to determine the tumor response rate of bi-weekly docetaxel plus 24-hour infusion of

  • high-dose 5-FU/leucovorin chemotherapy for patients with inoperable advanced gastric cancer.

Secondary Outcomes (5)

  • The rate of clinical benefit response defined by improvement in at least one of the 2 parameters

  • performance status and weight gain.

  • Toxicities of bi-weekly docetaxel plus 24-hour infusion of high-dose 5-FU/leucovorin chemotherapy

  • The patients'quality of life as evaluated by questionnaire interview Time to disease progression

  • Overall survival.

Interventions

Taxotere, Fluorouracil, LeucovorinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven and inoperable advanced gastric adenocarcinoma. 2.Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography scan). The index lesions should be at least 20 mm × 10 mm in size. 3.Age must be older than 18 and younger than 75 year-old. 4.Karnofsky performance status 60%. 5.Adequate bone marrow reserves, defined as white blood cell (WBC) 4,000/l, absolute neutrophil count (ANC)1,500/l, platelet 100,000/l. 6.Liver transaminases 2.5 times upper normal limit if no liver metastasis and 5 times upper normal limit if liver metastasis is present; total bilirubin 1.5 mg/dl; serum creatinine 1.5 mg/dl. 7.Serum triglyceride level 70 mg/dl. 8.Previous chemotherapy for metastatic disease is not allowed in this study. Previous adjuvant chemotherapy following curative gastrectomy is acceptable if the adjuvant chemotherapy has been completed for more than 6 months before enrollment into the present study. 9.Previous radiotherapy is allowed if the treatment was completed at least 4 weeks before the enrollment into this study. 10.Patients of childbearing age should have effective contraception during the study period. 11.All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.

You may not qualify if:

  • Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy. 2.Patients who refuse port-A catheter implantation. 3.Patients with brain or leptomeningeal metastases. 4.Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry. 5.Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy. 6.Life expectancy less than 2 months. 7.Pregnant or nursing women may not participate. Women or men with reproductive potential may not participate unless they have agreed to use an effective contraceptive method. 8.No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kun-Huei Yeh

Taipei, Ban-Ciao, 220, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

DocetaxelFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Kun Huei Yeh, Ph.D.

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Huei Yeh, Ph.D.

CONTACT

886-2-89667000khyeh@mail.femh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2005

First Posted

December 28, 2005

Last Updated

February 9, 2009

Record last verified: 2004-09

Locations

TW(1)