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

NCT00030485 | Completed Phase 2

• 4 other identifiers: I148CAN-NCIC-IND148NCI-NCIC-148CDR0000069169
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Endometrial Cancer

Keywords

stage IV endometrial carcinoma; recurrent endometrial carcinoma; endometrial adenocarcinoma; endometrial adenosquamous cell carcinoma

Interventions

erlotinib hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• NCIC Clinical Trials Group: collaborator

Study Sites (8)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre- Dame du CHUM

Montreal, Quebec, H4L 2M1, Canada

Location

Related Publications (2)

• 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.

  PMID: 18591547 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Amit M. Oza, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 27, 2014

Record last verified: 2011-01

Locations

CA (8)