Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer
The goal of this clinical research study is to learn how effective the drug pemetrexed (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (inability to perform every day activities without difficulty).
- PS = 2 cohort: Response
- PS = 3 cohort: Descriptive
- Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients
- Improved symptoms (both cohorts)
- Molecular Correlative studies (both cohorts)
- Overall survival
- Time to progression
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Agent Alimta in Poor Performance Status in Patients With Non-Small Cell Lung Cancer (NSCLC)|
- Objective Response Rate (OR) [ Time Frame: 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. ] [ Designated as safety issue: No ]
Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease assessed using same technique as baseline.
Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline.
Progression: One or more must occur: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician. Duration of response measured from date of maximum response (i.e., PR or CR) until date of progression.
|Study Start Date:||September 2005|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Alimta 500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks.
500 mg/m^2 by vein Once Over 10 Minutes Every 3 Weeks
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 status patients.
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 of pemetrexed.
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 stopping treatment.
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 University of Texas MD Anderson Cancer Center (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508144
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ralph Zinner, MD||M.D. Anderson Cancer Center|