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

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

Official Title
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A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erlotinib|150 mg in a single daily dose, starting Day 1 through Day 22|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean improvement of lung cancer symptoms as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy |  | 4 weeks post radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3 |  | 4 weeks post radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, palliative radiation, tarceva, palliative thoracic radiation therapy