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

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030485
First received: February 14, 2002
Last updated: January 24, 2014
Last verified: January 2011
  Purpose

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 Intervention Phase
Endometrial Cancer
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030485

Locations
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
NCIC Clinical Trials Group
Investigators
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00030485     History of Changes
Other Study ID Numbers: I148, CAN-NCIC-IND148, NCI-NCIC-148, CDR0000069169
Study First Received: February 14, 2002
Last Updated: January 24, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV endometrial carcinoma
recurrent endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma

Additional relevant MeSH terms:
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014