Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
![]() |
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: NCT00193414 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : March 3, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
Drug: Pemetrexed
500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
Other Name: Alimta Drug: Gemcitabine 1500mg/m2, 30min IV
Other Name: Gemzar |
- Overall Response Rate [ Time Frame: 18 months ]Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
- Progression-free Survival (PFS) [ Time Frame: 18 months ]PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
- Overall Survival (OS) [ Time Frame: 18 months ]OS was measured from the date of study entry until the date of death.

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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Histologically confirmed non-small cell bronchogenic carcinoma
- Newly diagnosed or recurrent unresectable stage III or stage IV disease
- No mixed tumors with small cell anaplastic elements
- Measurable disease
- Must not have received any prior antineoplastic chemotherapy for lung cancer
- Age > 18 years
- Able to perform activities of daily living with little or no assistance
- Adequate bone marrow, liver and kidney
- Understand the nature of this study and give written informed consent.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Female patients who are pregnant or are lactating
- History of serious cardiovascular disease within the previous six months
- Serious active infection at the time of treatment
- Other serious underlying medical condition
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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): NCT00193414
United States, Tennessee | |
Tennessee Oncology | |
Nashville, Tennessee, United States, 37203 |
Principal Investigator: | David R. Spigel, MD | SCRI Development Innovations, LLC |
Publications of Results:
Responsible Party: | SCRI Development Innovations, LLC |
ClinicalTrials.gov Identifier: | NCT00193414 |
Other Study ID Numbers: |
SCRI LUN 91 H3E-US-X011 |
First Posted: | September 19, 2005 Key Record Dates |
Results First Posted: | November 13, 2012 |
Last Update Posted: | March 3, 2022 |
Last Verified: | February 2022 |
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 |