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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic and/or locally advanced adenocarcinoma or adenosquamous carcinoma of the endometrium Incurable by standard therapies Clinically and/or radiologically documented disease with at least 1 unidimensionally measurable site At least 20 mm by x-ray, physical exam, or CT scan OR At least 10 mm by spiral CT scan Bone metastases considered nonmeasurable Tumor tissue from primary tumor available for assessing epidermal growth factor receptor (EGFR) status No uterine sarcomas (leiomyosarcoma), mixed mullerian tumors, and/or adenosarcomas No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No symptomatic congestive heart failure No unstable angina No cardiac arrhythmia Gastrointestinal: No gastrointestinal (GI) tract disease that would preclude ability to take oral medication No requirement for IV alimentation No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) No active peptic ulcer disease Ophthalmic: No significant ophthalmologic abnormalities, including any of the following: Prior severe dry eye syndrome, Sjogren's syndrome, or keratoconjunctivitis sicca Severe-exposure keratopathy Disorders that would increase the risk of epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) Congenital abnormality (e.g., Fuch's dystrophy) Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) No concurrent ocular inflammation or infection Other: No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix No prior allergic reaction attributed to compounds of similar biological or chemical composition to erlotinib No other concurrent serious illness or medical condition that would preclude study No prior significant neurologic or psychiatric disorder that would preclude study No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for endometrial cancer Endocrine therapy: No more than 1 prior hormonal therapy (progestational agent or aromatase inhibitor) in the adjuvant or metastatic setting At least 1 week since prior hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy (except for low-dose palliative radiotherapy) and recovered Surgery: At least 3 weeks since prior major surgery and recovered No prior surgical procedures affecting absorption No concurrent ophthalmic surgery Other: No prior EGFR-targeting therapies No other concurrent investigational therapy No other concurrent anticancer therapy Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to monitoring INR Concurrent low molecular weight heparin allowed at investigator's discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV endometrial carcinoma, recurrent endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma