Comparing 3 Schedules of Alimta Plus Gemzar

ID: NCT00034606
Status: Completed
Phase: Phase 2
Start Date: N/A
First Submitted: May 01, 2002
Last Updated: July 18, 2006
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: United States
Conditions: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms

Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)
Other Names
Phase 2

Tracking Information

First Submitted DateMay 01, 2002
Last Update Posted DateJuly 18, 2006
Start DateN/A
Completion DateN/A
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparing 3 Schedules of Alimta Plus Gemzar
Official Title
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
0
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None
Primary Purpose
Treatment
Conditions
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment0
Completion DateN/A
Eligibility Criteria: Inclusion Criteria:
- Diagnosis of non-small lung cancer
- No prior chemotherapy
- Able to care for self

Exclusion Criteria:
- An ongoing infection
- Pregnancy or breast feeding
- Other serious medical condition
- Cancer that has spread to the brain
- Inability to take folic acid
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00034606
Other Study ID Numbers
5115
H3E-MC-JMEL
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
Investigators
Not Available