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

Phase 2
Completed
Conditions
Endometrial Cancer
Registration Number
NCT00030485
Lead Sponsor
National Cancer Institute (NCI)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

🇨🇦

London, Ontario, Canada

British Columbia Cancer Agency

🇨🇦

Vancouver, British Columbia, Canada

Margaret and Charles Juravinski Cancer Centre

🇨🇦

Hamilton, Ontario, Canada

Hopital Notre- Dame du CHUM

🇨🇦

Montreal, Quebec, Canada

Tom Baker Cancer Center - Calgary

🇨🇦

Calgary, Alberta, Canada

Cross Cancer Institute

🇨🇦

Edmonton, Alberta, Canada

Kingston Regional Cancer Centre

🇨🇦

Kingston, Ontario, Canada

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