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

September 12, 2005
September 19, 2005
October 11, 2012
November 13, 2012
November 13, 2012
May 2005
December 2008   (Final data collection date for primary outcome measure)
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.
  • complete response rate
  • partial response rate
Complete list of historical versions of study NCT00193414 on Archive Site
  • 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.
  • progression-free survival
  • overall survival
  • toxicity
Not Provided
Not Provided
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
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.

Upon determination of eligibility, patients will be receive:

  • Pemetrexed + Gemcitabine
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • 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
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
  • Drug: Gemcitabine
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2009
December 2008   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Eli Lilly and Company
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP