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

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:

MedlinePlus related topics: Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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:

Published article in the Journal of Thoracic Oncology This link exits the ClinicalTrials.gov site

Publications:

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
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 Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Gemcitabine Pemetrexed Anti-Infective Agents	Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Folic Acid Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015