Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00061451
First Posted: May 29, 2003
Last Update Posted: December 22, 2010
Information provided by:
Eli Lilly and Company
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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:
- To assess time to objective tumor response for responding patients
- To assess duration of response for responding patients
- To assess time to treatment failure for patients
- To assess progression free survival of patients
- To assess time to progressive disease for patients
- To assess survival time for patients
- To characterize the toxicities of gemcitabine plus pemetrexed in this patient population
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2002 |
| Study Completion Date: | September 2006 |
Eligibility
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 4 weeks.
- Brain metastasis that is uncontrolled.
- Active infection or other serious condition.
Contacts and Locations
Information from the National Library of Medicine
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): NCT00061451
Locations
| United States, California | |
| 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. | |
| Palo Alto, California, United States | |
| United States, Missouri | |
| 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. | |
| Columbia, Missouri, United States | |
| 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. | |
| Kansas City, Missouri, United States | |
| United States, Montana | |
| 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 | |
| United States, Washington | |
| 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 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00061451 History of Changes |
| Other Study ID Numbers: |
7213 H3E-US-JMFY |
| First Submitted: | May 28, 2003 |
| First Posted: | May 29, 2003 |
| Last Update Posted: | December 22, 2010 |
| Last Verified: | December 2010 |
Additional relevant MeSH terms:
|
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 |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |