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Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
SCRI Development Innovations, LLC
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193414
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Lung Cancer | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
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 SCRI Development Innovations, LLC:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 74 |
| Study Start Date: | May 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
Upon determination of eligibility, patients will be receive:
- Pemetrexed + Gemcitabine
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193414
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193414
Locations
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Investigators
| Principal Investigator: | David R. Spigel, MD | SCRI Development Innovations, LLC |
More Information
Additional Information:
Publications:
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00193414 History of Changes |
| Other Study ID Numbers: |
SCRI LUN 91 H3E-US-X011 |
| Study First Received: | September 12, 2005 |
| Results First Received: | October 11, 2012 |
| Last Updated: | October 11, 2012 |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms 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 |
ClinicalTrials.gov processed this record on August 18, 2017