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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00030485

Collaborator

NCIC Clinical Trials Group (Other)

Locations

62.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: erlotinib hydrochloride	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
2	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
3	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
4	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
5	Kingston Regional Cancer Centre	Kingston	Ontario	Canada	K7L 5P9
6	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
7	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
8	Hopital Notre- Dame du CHUM	Montreal	Quebec	Canada	H4L 2M1