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

This study has been completed.
Sponsor:
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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial 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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 02, 2014