Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring stage IV endometrial carcinoma, recurrent endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma
Eligibility 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
Sites / Locations
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- British Columbia Cancer Agency
- Margaret and Charles Juravinski Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Princess Margaret Hospital
- Hopital Notre- Dame du CHUM