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

This study is currently recruiting participants.

Verified by Ontario Clinical Oncology Group (OCOG), November 2008

Sponsors and Collaborators:	Ontario Clinical Oncology Group (OCOG) Hoffmann-La Roche
Information provided by:	Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:	NCT00391248

Purpose

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

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Erlotinib	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

150 mg in a single daily dose, starting Day 1 through Day 22

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391248

Contacts

Contact: Jolanta Windsor

905-527-2299 ext 42618

windsor@mcmaster.ca

Locations

Canada, Ontario
Juravinski Cancer Centre	Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Jim Wright, MD 905-387-9495 ext 64706 jim.wright@hrcc.on.ca
Principal Investigator: Jim Wright, MD
Toronto Sunnybrook Regional Cancer Centre	Recruiting
Toronto, Ontario, Canada, M5N 3M5
Contact: Yee Ung, MD 416-480-4951 yee.ung@sunnybrook.ca
Principal Investigator: Yee Ung, MD

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Hoffmann-La Roche

Investigators

Principal Investigator:

Jim Wright, MD

Juravinski Cancer Centre

More Information

Responsible Party:	Ontario Clinical Oncology Group (OCOG) ( Dr. Mark Levine/Director OCOG )
Study ID Numbers:	CTA-Control-105472
Study First Received:	October 19, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00391248
Health Authority:	Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):

non-small cell lung cancer
palliative radiation
tarceva
palliative thoracic radiation therapy

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009