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Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00193414
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : November 13, 2012
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Pemetrexed Drug: Gemcitabine Phase 2

Detailed Description:

Upon determination of eligibility, patients will be receive:

  • Pemetrexed + Gemcitabine

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Overall Survival (OS) [ Time Frame: 18 months ]
    OS was measured from the date of study entry until the date of death.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


Locations
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United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Investigators
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Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
More Information
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Additional Information:
Published article in the Journal of Thoracic Oncology  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193414     History of Changes
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: November 13, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
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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