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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391248
• Other study ID #: CTA-Control-105472
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2006
• Last updated: January 28, 2013
• Start date: November 2006
• Est. completion date: December 2012

Study information

• Verified date: April 2011
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
150 mg in a single daily dose, starting Day 1 through Day 22

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Roche Pharma AG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No