Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT00061464
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purposes of this study are to determine:

1. The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.

2. Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.

3. Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.

4. To see if patients feel better while taking pemetrexed plus Gemcitabine.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-05-28
• Study First Submitted QC: 2003-05-28
• Study First Posted: 2003-05-29
• Study Completion: 2006-02
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy
• Have received no prior chemotherapy for Non-Small Cell Lung Cancer
• Have at least one measurable lesion
• Have an adequate performance status
• Sign an informed consent

Exclusion Criteria

• A female who is pregnant or breastfeeding
• Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed
• Treatment with radiation therapy within the last 1-2 weeks
• Brain metastasis that is uncontrolled
• Active infection or other serious condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).

Secondary Outcome Measures

Name	Time	Method
To measure time-to-event efficacy variables including:
time to objective tumor response for responding patients
duration of response for responding patients
time to treatment failure
time to progressive disease
progression-free survival
overall survival
To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician; 🇺🇸 Columbia, South Carolina, United States