Endometrial Cancer Clinical Trial
Official title:
A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor
cells and slow the growth of the tumor.
PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who
have locally advanced and/or metastatic endometrial cancer.
OBJECTIVES:
- Determine the efficacy of erlotinib, in terms of response rate and duration of stable
disease, in patients with locally advanced and/or metastatic carcinoma of the
endometrium.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and duration of response in patients treated with
this drug.
- Correlate objective tumor response with levels of epidermal growth factor receptor
expression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable
disease are also followed every 3 months until relapse or death.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18
months.
;
Primary Purpose: Treatment
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