Spots Global Cancer Trial Database for Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer

Official Title: A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium

Study ID: NCT00030485

Conditions

Endometrial Cancer

Interventions

erlotinib hydrochloride

Study Description

Brief Summary: 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.

Detailed Description: 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.