Status:
COMPLETED
Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and
- 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
- Previous erlotinib therapy; or
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00391248
Start Date
November 1 2006
End Date
December 1 2012
Last Update
January 29 2013
Active Locations (2)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
2
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M5N 3M5