Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
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The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy [ Time Frame: 4 weeks post radiotherapy ]
Secondary Outcome Measures :
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 [ Time Frame: 4 weeks post radiotherapy ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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