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

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Pemetrexed
Drug: Gemcitabine

Registration Number: NCT00193414

Lead Sponsor: SCRI Development Innovations, LLC

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Gemcitabine	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.
Intervention	Pemetrexed	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	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

Name	Time	Method
Progression-free Survival (PFS)	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.
Overall Survival (OS)	18 months	OS was measured from the date of study entry until the date of death.