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

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ClinicalTrials.gov Identifier: NCT00030485
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 27, 2014
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE January 2002
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Endometrial Cancer
Intervention  ICMJE Drug: erlotinib hydrochloride
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030485
Other Study ID Numbers  ICMJE I148
CAN-NCIC-IND148
NCI-NCIC-148
CDR0000069169 ( Other Identifier: PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE NCIC Clinical Trials Group
Investigators  ICMJE
Study Chair: Amit M. Oza, MD Princess Margaret Hospital, Canada
PRS Account National Cancer Institute (NCI)
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP