Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus Clinical Trial
Official title:
Lapatinib (GW572016) a Dual Inhibitor of EGFR and ErbB2, for Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus
The purpose of this study is the determine whether a new compound, called lapatinib, can be effective in shrinking cancerous tumors of the esophagus that have recurred or spread somewhere else in the body. They also want to determine the toxicity of this regimen. Lapatinib blocks 2 receptors that sometimes are present on cancer cells (called epidermal growth factor receptor, and the Erb B2 receptor). It is possible that blocking these receptors may decrease the growth of the cancer cells.
The subject will take an oral pill called Lapatinib. Each tablet is 250 mg. Subjects will
take 1500mg (six 250mg tablets) of lapatinib once daily. Subjects must fast 1 hour prior to
and 1 hour following dosing. If a subject is unable to swallow lapatinib tablets whole, the
lapatinib may be crushed with a mortar and pestle to form a powder, and mix it in 4 oz (120
ml) of water to take by mouth or through a feeding tube. Then the subject will then rinse
the mortar with 2 oz (60ml) of water to suspend the left-over powder, and then swallow the
rinse or flush it down the feeding tube. You will have to repeat this rinse one more time.
Subjects will have a "MUGA" scan done at the very beginning to make sure that heart function
is good. It will then be repeated every other month while on treatment. When the subjects
have a MUGA scan, 3 cc's (less than one teaspoon) of blood will be drawn from your vein, and
labeled with a radioactive substance. Then, subjects blood will be injected back into
his/her arm through a catheter in your vein. The level of radiation you will be exposed to
is very minimal. Then, a camera will take a "movie" of your heart. The entire procedure
lasts about 90 minutes.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment