NCT00034606

Brief Summary

The purpose of the study is to measure tumor response rates for three schedules of Alimta(LY231514) in combination with gemcitabine in patients with locally advanced or metastatic non small cell lung cancer who have received no prior chemotherapy regimen.

Trial Health

80
On Track

Trial Health Score

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

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

First Submitted

Initial submission to the registry

May 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2002

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

May 1, 2002

Last Update Submit

July 18, 2006

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasms

Keywords

Lung cancercancerneoplasmnon-smallchemotherapy

Interventions

Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)DRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of non-small lung cancer
  • No prior chemotherapy
  • Able to care for self

You may not qualify if:

  • An ongoing infection
  • Pregnancy or breast feeding
  • Other serious medical condition
  • Cancer that has spread to the brain
  • Inability to take folic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rochester, Minnesota, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasms

Interventions

PemetrexedGemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

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

Study Record Dates

First Submitted

May 1, 2002

First Posted

May 2, 2002

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations

US(1)