Back to resultsPemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- Tennessee Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Response Rate
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.
Secondary Outcome Measures
Progression-free Survival (PFS)
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)
OS was measured from the date of study entry until the date of death.
Full Information
NCT ID
NCT00193414
First Posted
September 12, 2005
Last Updated
February 21, 2022
Sponsor
SCRI Development Innovations, LLC
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00193414
Brief Title
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Official Title
Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.
Detailed Description
Upon determination of eligibility, patients will be receive:
Pemetrexed + Gemcitabine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1500mg/m2, 30min IV
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
18 months
Title
Overall Survival (OS)
Description
OS was measured from the date of study entry until the date of death.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spigel, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20421819
Citation
Spigel DR, Hainsworth JD, Barton JH, Patton JF, Zubkus JD, Simons L, Griner P, Burris HA 3rd, Greco FA. Phase II study of biweekly pemetrexed and gemcitabine in patients with previously untreated advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):841-5. doi: 10.1097/JTO.0b013e3181d737e3.
Results Reference
result
Links:
URL
http://journals.lww.com/jto/pages/articleviewer.aspx?year=2010&issue=06000&article=00015&type=abstract
Description
Published article in the Journal of Thoracic Oncology
Learn more about this trial
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
We'll reach out to this number within 24 hrs