Clinical trial NCT00193414: Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Official title: Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Upon determination of eligibility, patients will be receive:

* Pemetrexed + Gemcitabine

Eligibility 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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: 18 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.