Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT00071136 |
Recruitment Status :
Completed
First Posted : October 16, 2003
Last Update Posted : January 26, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Neoplasms | Drug: pemetrexed Drug: gemcitabine | Phase 1 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: | Phase 1/2 Dose-Escalating Study of Biweekly Alimta and Gemcitabine in Patients With Advanced Cancer |
Study Start Date : | December 2003 |
Study Completion Date : | August 2006 |

- To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.
- To measure the effects of chemotherapy treatment on:
- time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive;
- To measure the side-effects from this chemotherapy as given once every 14 days.

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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:
- Have a diagnosis of advanced stage non-small cell lung cancer.
- Are able to be active at home and/or work.
- Have not received chemotherapy for this cancer disease.
- Have good organ function (for example, most blood work is normal).
- Have completed any prior radiation treatment at least 4 weeks ago.
Exclusion Criteria:
- Have been treated with an investigational/research drug within the last month.
- Have cancer that has spread to the brain and is causing symptoms.
- Have an active infection or other serious medical condition.
- Have a second cancer in addition to non-small cell lung cancer.
- Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.

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): NCT00071136
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. | |
Ft. Myers, Florida, United States | |
United States, Minnesota | |
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. | |
Marshfield, Minnesota, United States | |
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. | |
Minneapolis, Minnesota, United States | |
United States, New York | |
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. | |
Rochester, New York, United States | |
United States, Texas | |
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. | |
Dallas, Texas, 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: | NCT00071136 |
Other Study ID Numbers: |
7221 H3E-US-JMGC |
First Posted: | October 16, 2003 Key Record Dates |
Last Update Posted: | January 26, 2007 |
Last Verified: | January 2007 |
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 |