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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)

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

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

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;

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy

Outcome Time Frame:

4 weeks post radiotherapy

Safety Issue:


Principal Investigator

Jim Wright, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Juravinski Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

November 2006

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • palliative radiation
  • tarceva
  • palliative thoracic radiation therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms