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

NCT00391248 | Completed Phase 2 DMC

• 1 other identifier: CTA-Control-105472
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

Erlotinib DRUG

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

Also known as: Tarceva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Roche Pharma AG: collaborator

Study Sites (2)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M5N 3M5, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jim Wright, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 23, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 29, 2013

Record last verified: 2011-04

Locations

CA (2)