Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00061464 |
Recruitment Status :
Completed
First Posted : May 29, 2003
Last Update Posted : January 26, 2007
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The purposes of this study are to determine:
- The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
- Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
- Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
- To see if patients feel better while taking pemetrexed plus Gemcitabine.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung | Drug: pemetrexed Drug: gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 48 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase II Clinical Trial |
Study Start Date : | February 2003 |
Study Completion Date : | February 2006 |

- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061464
United States, Florida | |
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 | |
Miami, Florida, United States | |
United States, Illinois | |
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 | |
Chicago, Illinois, United States | |
United States, Louisiana | |
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 | |
Shreveport, Louisiana, United States | |
United States, South Carolina | |
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 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00061464 |
Other Study ID Numbers: |
7211 H3E-US-JMFX |
First Posted: | May 29, 2003 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed |
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