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

Ontario Clinical Oncology Group (OCOG)

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00391248

CTA-Control-105472

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)