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

Phase 2CompletedNCT00193414

SCRI Development Innovations, LLC72 enrolled

Overview

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.

Upon determination of eligibility, patients will be receive: * Pemetrexed + Gemcitabine

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

PemetrexedDRUG

500mg/m2 IV over 10 min, Day 1, prior to gemcitabine

GemcitabineDRUG

1500mg/m2, 30min IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tennessee Oncology

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 18 months

Overall Survival (OS)

OS was measured from the date of study entry until the date of death.

Time frame: 18 months

Data from ClinicalTrials.gov

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