Endometrial Cancer
Conditions
Keywords
stage IV endometrial carcinoma, recurrent endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Countries
Canada