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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, palliative radiation, tarceva, palliative thoracic radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Juravinski Cancer Centre
  • Toronto Sunnybrook Regional Cancer Centre

Outcomes

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

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

Full Information

First Posted
October 19, 2006
Last Updated
January 28, 2013
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00391248
Brief Title
Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
non-small cell lung cancer, palliative radiation, tarceva, palliative thoracic radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg in a single daily dose, starting Day 1 through Day 22
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Wright, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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