Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
Phase 2
Completed
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT00391248
- Lead Sponsor
- Ontario Clinical Oncology Group (OCOG)
- Brief Summary
To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada