Status:
TERMINATED
Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 followi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients must have metastatic or recurrent squamous cell carcinoma of the esophagus.
- 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 marrow.
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00239200
Start Date
October 1 2005
End Date
September 1 2007
Last Update
July 30 2008
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109