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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030485
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 27, 2014
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)

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:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Platelet count at least 100,000/mm3
  • Absolute granulocyte count at least 1,500/mm3


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No symptomatic congestive heart failure
  • No unstable angina
  • No cardiac arrhythmia


  • 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


  • 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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • At least 4 weeks since prior radiotherapy (except for low-dose palliative radiotherapy) and recovered


  • At least 3 weeks since prior major surgery and recovered
  • No prior surgical procedures affecting absorption
  • No concurrent ophthalmic surgery


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030485

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Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada, H4L 2M1
Sponsors and Collaborators
National Cancer Institute (NCI)
NCIC Clinical Trials Group
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Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
Publications of Results:
Oza A, Elit L, Eisenhauer E, et al.: Phase II study of erlotinib (Tarceva, OSI 774) in women with recurrent or metastatic endometrial cancer -- NCIC IND.148. [Abstract] Clin Cancer Res 9 (Suppl): A-105, 6094s, 2003.

Layout table for additonal information Identifier: NCT00030485    
Other Study ID Numbers: I148
CDR0000069169 ( Other Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2011
Keywords provided by National Cancer Institute (NCI):
stage IV endometrial carcinoma
recurrent endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action