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

Lung Cancer Clinical Trial

Official title:

Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193414
• Other study ID #: SCRI LUN 91
• Secondary ID: H3E-US-X011
• Status: Completed
• Phase: Phase 2
• Start date: May 2005
• Est. completion date: August 2009

Study information

• Verified date: February 2022
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Upon determination of eligibility, patients will be receive:

• Pemetrexed + Gemcitabine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Pemetrexed
500mg/m2 IV over 10 min, Day 1, prior to gemcitabine
• Gemcitabine
1500mg/m2, 30min IV

Locations

Country	Name	City	State
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	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.	18 months
Secondary	Progression-free Survival (PFS)	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.	18 months
Secondary	Overall Survival (OS)	OS was measured from the date of study entry until the date of death.	18 months

External Links

•   Published article in the Journal of Thoracic Oncology