Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
NCT ID: NCT00391248
Last Updated: 2013-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2006-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Erlotinib
150 mg in a single daily dose, starting Day 1 through Day 22
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and
* At least 18 years of age.
Exclusion Criteria
* Planned concurrent chemotherapy; or
* Expected survival of less than 3 months; or
* ECOG Performance Status of 3 or 4; or
* Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or
* Granulocyte count \<1,500/mm3, platelet count \<100,000/mm3, or haemoglobin \<9.0g/dl; or
* SGOT (AST) or SGPT (ALT) \> 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or \> 5 x ULN in case of known liver metastases; or
* Alkaline phosphatase (ALP) \> 2.5 x ULN; or
* Serum bilirubin \> 1.5 ULN; or
* Serum creatinine \> 1.5 ULN or creatinine clearance \< 60 ml/min; or
* Serum calcium beyond ULN; or
* Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or
* A history of interstitial lung disease; or
* Known sensitivity to erlotinib; or
* Pregnancy, lactation, or parturition within the previous 30 days; or
* Unwillingness or inability to complete the required assessments of the trial; or
* Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or
* History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye.
* Geographically inaccessible for treatment or follow-up evaluations; or
* Involved in an ongoing therapeutic trial.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Ontario Clinical Oncology Group (OCOG)
OTHER
Responsible Party
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Principal Investigators
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Jim Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre
Locations
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Juravinski Cancer Centre
Hamilton, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CTA-Control-105472
Identifier Type: -
Identifier Source: org_study_id
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