Brief Title
Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
Official Title
A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
erlotinib hydrochloride
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
January 2002
Completion Date
April 2007
Primary Completion Date
April 2007
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amit M. Oza, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00030485
Organization ID
I148
Secondary IDs
CAN-NCIC-IND148
Study Sponsor
National Cancer Institute (NCI)
Collaborators
NCIC Clinical Trials Group
Study Sponsor
Amit M. Oza, MD, Study Chair, Princess Margaret Hospital, Canada
Verification Date
January 2011