A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Status:	Completed
Conditions:	Lung Cancer, Lung Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/23/2016
Start Date:	July 2004
End Date:	March 2008

A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to
gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC).
Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that
pemetrexed plus cisplatin may be as effective and may have fewer side effects than the
standard of care.

Inclusion Criteria:

- Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.

- No prior chemotherapy for lung cancer.

- Patients must have at least one uni-dimensionally measurable lesion.

- Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed.
Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion Criteria:

- Treatment with any drug within the last 30 days that has not received regulatory
approval.

- Serious cardiac condition.

- Serious medical disorder in addition to NSCLC that would make it difficult for the
patient to complete the study.

- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

- Presence of fluid retention that cannot be controlled by drainage.

We found this trial at

sites

Clinical Trial Facility in Nashville Tennessee

Nashville, Tennessee 37232

from

Nashville, TN