NCT00173888

Brief Summary

The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

9.3 years

First QC Date

September 8, 2005

Last Update Submit

December 4, 2012

Conditions

Non-small Cell Lung Cancer

Keywords

Combination, Chemotherapy,non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens.

    2003~2009

Secondary Outcomes (1)

  • To evaluate the response rate for each regimen, the toxicity of each arm, and the duration of response

    2003~2009

Study Arms (2)

A

EXPERIMENTAL
Drug: Docetaxel, Cisplatin

B

ACTIVE COMPARATOR
Drug: Gemcitabine, Cisplatin

Interventions

Docetaxel, CisplatinDRUG

docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15

A
Gemcitabine, CisplatinDRUG

gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15

B

Eligibility Criteria

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

You may qualify if:

  • Histologic or cytologic diagnosis of stage IIIB/IV NSCLC, no prior chemotherapy
  • Age \> 18 years and \< 75 years
  • WHO PS: 0,1
  • Unidimensional or bi-dimensional measurable disease
  • Neutrophils \> 1.5 109/l, Platelets \> 100 109/l, Hemoglobin \> 10g/dl, Total bilirubin \< 1.5 UNL, AST (SGOT) and ALT (SGPT) \< 2.5 UNL, Alkaline phosphatases \< 5 UNL; except in presence of only bone metastasis and in the absence of any liver disorders
  • Creatinine \< 1 UNL, and creatinine clearance should be \> 60 ml/min.
  • Life expectancy \> 12 weeks

You may not qualify if:

  • Pregnant, or lactating patients
  • Known clinical brain or leptomeningeal involvement
  • Pre-existing motor or sensory neurotoxicity of a severity \> grade 1 by NCIC-CTG criteria
  • CHF, angina or arrhythmias
  • History of significant neurological or psychiatric disorders
  • Active uncontrolled infection
  • Contraindication for the use of corticosteroids
  • Concurrent treatment with other experimental drugs within 30 days prior to study entry
  • Concurrent treatment with any other anti-cancer therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelCisplatinGemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Chih-Hsin Yang, M.D.,Ph.D.

    Department of Oncology , National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Ann-Lii Cheng, M.D.,Ph.D.

    Department of Oncology , National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 15, 2005

Study Start

July 1, 2003

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

TW(1)