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Lapatinib (GW572016) a Dual Inhibitor of EGFR and ErbB2, for Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

Phase 2
18 Years
Not Enrolling
Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

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Trial Information

Lapatinib (GW572016) a Dual Inhibitor of EGFR and ErbB2, for Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus

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.

Inclusion Criteria:

- Patients must have metastatic or recurrent squamous cell carcinoma of the

- Patients must have histologically or cytologically confirmed disease.

- Patients may have received one prior regimen of neoadjuvant chemotherapy or
chemoradiation, and prior esophagectomy is acceptable. Patients may also have
received one prior chemotherapy regimen for recurrent disease.

- Patients may have received no more than 4500 cGy to fields including substantial

- Age greater than or equal than 18 years. Because no dosing or adverse event data are
currently available on the use of GW572016 in patients <18 years of age, children are
excluded from this study.

- Life expectancy of greater than 12 weeks.

- Patients must have normal organ and marrow function as defined below:

Leukocytes greater than or equal to 3,000/microliters Absolute neutrophil count greater
than or equal to 1,500/microliters Platelets greater than or equal to 100,000/microliters
Total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT)less than or equal
to 2.5 X institutional upper limit of normal Creatine within normal institutional limits
OR creatinine clearance greater than or equal to 60 ml/min for patients with creatinine
levels above institutional normal

-Cardiac ejection fraction within the institutional range of normal as measured by
echocardiogram or MUGA scan. A normal ejection fraction is equal or greater than 50%.
Baseline and on treatment scans should be performed using the same modality and preferably
at the same institution.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Outcome:


United States: Food and Drug Administration

Study ID:

UMCC 2005-037



Start Date:

October 2005

Completion Date:

September 2007

Related Keywords:

  • Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752