Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00061451
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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- Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.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 4 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 assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.
- Secondary Outcome Measures
Name Time Method To assess duration of response for responding patients To assess time to treatment failure for patients To assess time to objective tumor response for responding patients To assess progression free survival of patients To assess survival time for patients To characterize the toxicities of gemcitabine plus pemetrexed in this patient population To assess time to progressive disease for patients
Trial Locations
- Locations (2)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Seattle, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Great Falls, Montana, United States