Single Agent Alimta in Poor Performance Status in Patients With Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed is designed to block enzymes in the body that are important for tumor growth.
Pemetrexed is commercially approved for the treatment of NSCLC but not for poor performance
If you are found to be eligible to take part in this study, you will receive pemetrexed once
every 3 weeks through a needle in your vein over about 10 minutes. Every 3 weeks is
considered 1 treatment cycle. Once the treatment has started, you will return to the clinic
before every treatment cycle. At these visits, you will have a physical exam, a performance
status evaluation, and routine blood (about 3-4 teaspoons) and urine tests. You will have a
chest x-ray and you will be asked to complete a questionnaire about how you are feeling. You
will also have a CT or MRI scan after Cycle 1 and every odd cycle from then on.
You are required to take folic acid by mouth every day for 5 days before the first dose of
pemetrexed and continuing until 3 weeks after your last dose of pemetrexed. You will also
receive an injection of vitamin B12 into your muscle before your first dose of pemetrexed.
The vitamin B12 injection will be repeated every 9 weeks until 3 weeks after your last dose
You will also to take a few low-dose steroid (dexamethasone) tablets twice a day before
treatment, the day of treatment, and the day after each treatment. These will be taken to
decrease the risk of rash and nausea caused by pemetrexed.
You may continue treatment with pemetrexed until your tumor grows or an unacceptable side
effect occurs. You will be evaluated for symptoms 1-2 times per week while you are
receiving treatment and then 2 weeks after stopping study treatment until 6 months after
When you stop treatment on this study, you will have a physical exam, routine blood (3-4
teaspoons) and urine tests, and a chest x-ray. The study doctor may ask you to visit
UTMDACC or be contacted by phone for follow-up on how you are doing.
This is an investigational study. The FDA has approved pemetrexed for the treatment of
advanced NSCLC after earlier treatment with chemotherapy, and for the treatment for
malignant mesothelioma in combination with cisplatin. About 70 patients will take part in
this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (OR)
Evaluated for symptoms 1-2 times per week while receiving treatment and then 2 weeks after stopping study treatment until 6 months after stopping treatment have physical exams, routine blood and urine tests, and a chest x-ray.
Ralph Zinner, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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