Phase II Trial of Erlotinib and Concurrent Palliative Tho... | NCT00391248

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

NCT00391248

Sponsor

Ontario Clinical Oncology Group (OCOG)

Status

Completed

Last Update Posted

Jan 29, 2013Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

Erlotinib

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 19, 2006

First Submission Date that Met QC Criteria

Oct 19, 2006

First Posted Date

Oct 23, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2013

Last Update Posted Date

Jan 29, 2013Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Erlotinib	Drug	150 mg in a single daily dose, starting Day 1 through Day 22		Tarceva

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Juravinski Cancer Centre		Hamilton	Ontario	L8V 1C3	Canada
Toronto Sunnybrook Regional Cancer Centre

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds