Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00061464
First received: May 28, 2003
Last updated: January 24, 2007
Last verified: January 2007
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
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 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:
- 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.
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | February 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 1-2 weeks
- Brain metastasis that is uncontrolled
- Active infection or other serious condition
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061464
Locations
| 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 | |
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00061464 History of Changes |
| Other Study ID Numbers: | 7211, H3E-US-JMFX |
| Study First Received: | May 28, 2003 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013