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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer  Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
For Condition: endometrial adenosquamous cell carcinoma,stage 4 endometrial cancer,recurrent endometrial cancer,endometrial adenocarcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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 metastaticendometrial cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmitOza, Study Chair, Princess Margaret Hospital
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Hopital Notre- Dame du CHUM
Montreal, Quebec, H4L 2M1
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Additional Information:
Study ID Numbers: CDR0000069169; CAN-NCIC-IND148,NCI-NCIC-148
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030485
Other Endometrial Adenocarcinoma Studies:
1. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
2. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
3. Liposomal Doxorubicin in Treating Patients with Advanced or Recurrent Endometrial Cancer
4. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Related Studies:
Other endometrial adenocarcinoma Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
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