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

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

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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Published article in the Journal of Thoracic Oncology 

Publications of Results:

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.

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
Results First Posted:	November 13, 2012
Last Update Posted:	November 13, 2012
Last Verified:	October 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