Clinical trial NCT00391248: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
palliative radiation
tarceva
palliative thoracic radiation therapy
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2006-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy
timeFrame: 4 weeks post radiotherapy
Secondary outcomes:
measure: 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
timeFrame: 4 weeks post radiotherapy
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre
name: Jim Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: