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WBRT & Erlotinib in Advanced NSCLC and Brain Metastases (TACTIC)

Primary Purpose

Lung Cancer, Metastatic Cancer

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
erlotinib hydrochloride
placebo
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring tumors metastatic to brain, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

    • Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy
    • Relapsed NSCLC with newly diagnosed multiple brain metastases
    • Relapsed after second-line chemotherapy with newly diagnosed multiple brain metastases NOTE: *Biopsy of brain metastases is not required
  • Diagnosis of brain metastases must be confirmed by contrast CT scan or MRI within the past 4 weeks

    • Symptoms attributable to brain metastases
    • Patients who have undergone craniotomy with incomplete resection are eligible
  • Clinician certain that whole-brain radiotherapy (WBRT) will be beneficial
  • No evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
  • No more than 3 sites (organ systems) of extracranial metastases

    • No liver metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • RTOG recursive partitioning analysis (RPA) class I or II
  • Serum bilirubin < 2 times upper limit of normal (ULN)
  • AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
  • Creatinine < 5 times ULN
  • Able to take oral medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Caretaker able and willing to participate in the study
  • Patient and caretaker have access to a telephone and willing to respond to telephone interview
  • No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
  • No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications including, but not limited to, any of the following:

    • Severe uncontrolled infection
    • Unstable angina
    • Myocardial infarction within the past month
    • Uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
    • Acute renal failure

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 28 days since prior chemotherapy (for relapsed patients originally treated with chemotherapy)
  • No prior cranial radiotherapy
  • No prior anti-cancer EGFR therapy (e.g., erlotinib, gefitinib, or cetuximab)
  • No prior treatment for brain metastases (e.g., radiosurgery, radiotherapy, or chemotherapy)

    • Prior radiotherapy to the primary tumor and/or systemic treatment to metastatic sites of disease allowed
  • No concurrent cyclooxygenase-2 (COX-2) inhibitors

Sites / Locations

  • Charing Cross Hospital
  • University College of London Hospitals
  • Christie Hospital
  • Salisbury District Hospital
  • Southampton General Hospital
  • Glan Clwyd Hospital
  • South West Wales Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

erlotinib hydrochloride

placebo

Arm Description

WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months

WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm

Outcomes

Primary Outcome Measures

Neurological progression-free survival at 2 months

Secondary Outcome Measures

Toxicity
Response rate
Quality of life
Change in performance status
Steroid dosing
Sites of progression (cranial or extracranial)

Full Information

First Posted
November 6, 2007
Last Updated
December 9, 2011
Sponsor
University College, London
Collaborators
Cancer Research UK, Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00554775
Brief Title
WBRT & Erlotinib in Advanced NSCLC and Brain Metastases
Acronym
TACTIC
Official Title
A Randomised Phase II Double Blind Placebo Controlled Trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Multiple Brain Metastases [TACTIC]
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
IDMC made a recommendation to stop the trial as the target for continuing to the 2nd phase was not met.
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Cancer Research UK, Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases. PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.
Detailed Description
OBJECTIVES: Primary Compare the effect of whole-brain radiotherapy (WBRT) and erlotinib hydrochloride vs WBRT alone on neurological progression-free survival at 2 months in patients with advanced non-small cell lung cancer and multiple brain metastases. Secondary Compare the toxicity of these regimens. Compare the response rate in these patients. Compare quality of life of these patients. Compare change in performance status in these patients. Compare steroid dosing in these patients. Compare sites of progression (cranial or extracranial) in these patients. OUTLINE: This is a multicenter study. Patients are stratified by presence of extracranial metastases (yes vs no), RTOG recursive partitioning analysis (RPA) score (I vs II) and treatment center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily for 5 days. Patients also receive oral erlotinib hydrochloride once daily for up to 24 months. Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once daily for up to 24 months. Quality of life is assessed at baseline, monthly for 12 months, and then at 18 and 24 months. After completion of study therapy, patients are followed every 1-2 months. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Cancer
Keywords
tumors metastatic to brain, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erlotinib hydrochloride
Arm Type
Experimental
Arm Description
WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
tarceva, OSI-774
Intervention Description
PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride
Primary Outcome Measure Information:
Title
Neurological progression-free survival at 2 months
Time Frame
at 2 months
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
during and for 28 days following Tarceva/placebo treatment.
Title
Response rate
Time Frame
from date of randomisation to radiological progression
Title
Quality of life
Time Frame
completed monthly for the first 12 months and at 18 and 24 months from randomisation
Title
Change in performance status
Time Frame
from baseline
Title
Steroid dosing
Time Frame
from baseline
Title
Sites of progression (cranial or extracranial)
Time Frame
from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy Relapsed NSCLC with newly diagnosed multiple brain metastases Relapsed after second-line chemotherapy with newly diagnosed multiple brain metastases NOTE: *Biopsy of brain metastases is not required Diagnosis of brain metastases must be confirmed by contrast CT scan or MRI within the past 4 weeks Symptoms attributable to brain metastases Patients who have undergone craniotomy with incomplete resection are eligible Clinician certain that whole-brain radiotherapy (WBRT) will be beneficial No evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy No more than 3 sites (organ systems) of extracranial metastases No liver metastases PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% RTOG recursive partitioning analysis (RPA) class I or II Serum bilirubin < 2 times upper limit of normal (ULN) AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present) Creatinine < 5 times ULN Able to take oral medication Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Caretaker able and willing to participate in the study Patient and caretaker have access to a telephone and willing to respond to telephone interview No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications including, but not limited to, any of the following: Severe uncontrolled infection Unstable angina Myocardial infarction within the past month Uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Acute renal failure PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 28 days since prior chemotherapy (for relapsed patients originally treated with chemotherapy) No prior cranial radiotherapy No prior anti-cancer EGFR therapy (e.g., erlotinib, gefitinib, or cetuximab) No prior treatment for brain metastases (e.g., radiosurgery, radiotherapy, or chemotherapy) Prior radiotherapy to the primary tumor and/or systemic treatment to metastatic sites of disease allowed No concurrent cyclooxygenase-2 (COX-2) inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siow M. Lee, MD, PhD, FRCP
Organizational Affiliation
University College London Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
South West Wales Cancer Institute
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

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WBRT & Erlotinib in Advanced NSCLC and Brain Metastases

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