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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00391248
• Date of registration: 19/10/2006
• Prospective Registration: Yes
• Primary sponsor: Ontario Clinical Oncology Group (OCOG)
• Public title: Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
• Scientific 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)
• Date of first enrolment: November 2006
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00391248
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Jim Wright, MD
• Affiliation: Juravinski Cancer Centre

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Intervention(s)

Drug: Erlotinib

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

CTA-Control-105472

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG