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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: NCIC Clinical Trials Group
• Treatments: Erlotinib Hydrochloride

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