NCT00319800

Brief Summary

To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

First QC Date

April 28, 2006

Last Update Submit

March 10, 2008

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Objective response rate

  • Progression-free survival

Secondary Outcomes (2)

  • Overall survival

  • Toxicity

Interventions

GefitinibDRUG
IrinotecanDRUG

Eligibility Criteria

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

You may qualify if:

  • aged 75 years or less
  • histologically or cytologically confirmed non-small cell lung cancer
  • advanced, metastatic or recurrent
  • ECOG performance status 0 to 2
  • one prior palliative chemotherapy including docetaxel
  • measurable or evaluable indicator lesion(s)
  • normal marrow, hepatic and renal function
  • provision of written informed consent

You may not qualify if:

  • active infection and/or severe comorbidities
  • pregnant or breastfed women
  • active CNS metastasis
  • active bleeding in GI tract or elsewhere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405 760, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GefitinibIrinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCamptothecinAlkaloids

Study Officials

  • Se Hoon Park, MD

    Gachon University Gil Medical Center, Incheon, Korea

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 28, 2006

First Posted

April 27, 2006

Study Start

February 1, 2006

Study Completion

March 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

KR(1)