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

• 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: SCRI Development Innovations, LLC
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): SCRI Development Innovations, LLC

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: N/A
• 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

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

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

• 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

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:

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
• 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; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; 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