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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
erlotinib hydrochloride
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage IV endometrial carcinoma, recurrent endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute
  • British Columbia Cancer Agency
  • Margaret and Charles Juravinski Cancer Centre
  • Kingston Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Princess Margaret Hospital
  • Hopital Notre- Dame du CHUM

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
January 24, 2014
Sponsor
National Cancer Institute (NCI)
Collaborators
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00030485
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
NCIC Clinical Trials Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
stage IV endometrial carcinoma, recurrent endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit M. Oza, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre- Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4L 2M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18591547
Citation
Oza AM, Eisenhauer EA, Elit L, Cutz JC, Sakurada A, Tsao MS, Hoskins PJ, Biagi J, Ghatage P, Mazurka J, Provencher D, Dore N, Dancey J, Fyles A. Phase II study of erlotinib in recurrent or metastatic endometrial cancer: NCIC IND-148. J Clin Oncol. 2008 Sep 10;26(26):4319-25. doi: 10.1200/JCO.2007.15.8808. Epub 2008 Jun 30.
Results Reference
result
Citation
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.
Results Reference
result

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

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