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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Pemetrexed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193414

SCRI LUN 91

H3E-US-X011

Details and patient eligibility

About

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.

Full description

Upon determination of eligibility, patients will be receive:

• Pemetrexed + Gemcitabine

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Pemetrexed

Drug: Gemcitabine