Comparing 3 Schedules of Alimta Plus Gemzar

Neoplasms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034606
• Other study ID #: 5115
• Secondary ID: H3E-MC-JMEL
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2002
• Last updated: July 18, 2006

Study information

• Verified date: July 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasms

Intervention

Drug:
• Pemetrexed (Alimta) in combination with gemcitabine (Gemzar)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,