A Phase I Dose Escalation Study of Pemetrexed in Patients With Advanced Head and Neck Squamous Cell Cancer
Pemetrexed is designed to block enzymes in the body that are important for tumor growth.
If you are found to be eligible to take part in this study, you will be assigned to one of 3
groups. All participants will receive pemetrexed once every 3 weeks through a needle in the
vein over about 10 minutes. Every 3 weeks is considered 1 cycle. Participants in Group 1
will receive pemetrexed only. Participants in Group 2 will also receive dexamethasone on Day
1 of each cycle through a needle in the vein. Participants in Group 3 will take
dexamethasone by mouth the day before, the day of, and the day after receiving pemetrexed.
Three (3) different dose levels of pemetrexed will be studied. The first group of 6
participants will be treated at Dose Level 1 (lowest of the 3 doses) and evaluated for 3
weeks. If 0 or 1 out of 6 participants experience severe side effects at Dose Level 1, the
next group of 6 participants will be treated at Dose Level 2. At any given dose, if greater
than 1 out of 6 participants experience severe side effects, then no further participants
will receive that dose or a higher dose.
Every 3 weeks (each cycle), you will have a physical exam, including measurement of vital
signs (temperature, pulse, breathing rate, and blood pressure) and weight. Blood (about 3-4
teaspoons) will be collected for routine tests. A performance status evaluation (a test
looking at the ability to perform everyday activities) and a liver function test will also
be done. Your tumor will be evaluated by CT scan and chest x-ray every 2 cycles of study
While on study, you will be required to take folic acid by mouth every day for 5-7 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 1 to 2 weeks
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. It is very important that folic
acid and vitamin B12 be given to decrease the risk of severe side effects from the
You may receive up to 6 cycles of treatment. You will be taken off study if the disease
gets worse or intolerable side effects occur. When you stop taking study drug on this study,
you will have a physical exam, including measurement of vital signs (temperature, pulse,
breathing rate, and blood pressure) and weight. Blood (about 3-4 teaspoons) will be
collected for routine tests. A performance status evaluation (a test looking at the ability
to perform everyday activities) and a liver function test (about 1-2 teaspoons of blood)
will also be done.
After completion of 6 cycles of treatment, you will be asked to return to the clinic for
follow-up visits every 2-3 months for standard follow-up.
This is an investigational study. The FDA has approved pemetrexed for the treatment of
non-small cell lung cancer. However, the FDA has authorized pemetrexed for research only in
the patients with HNSCC. Between 40-50 patients will take part in this study. All will be
enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Pemetrexed
MTD for pemetrexed within each schedule of dexamethasone is defined as the highest dose level in which less than 2 instances of dose limiting toxicities (DLT) observed out of 6 treated participants.
Edward Kim, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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