Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Roche Pharma AG
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.