Back to resultsQOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
Primary Purpose
Lung Cancer, Metastatic Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
erlotinib hydrochloride
temozolomide
stereotactic radiosurgery
Sponsored by
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
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer meeting the following criteria:
One to 3 brain metastases, meeting the following criteria:
- No larger than 3 cm
- Greater than 5 mm from the optic apparatus
- Not involving the brainstem, pons, medulla, or midbrain
Stable systemic disease for the past 3 months
- Less than 3 months since completion of primary treatment
- Measurable CNS disease as defined by RECIST criteria
- No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic evaluation
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 12 weeks
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 3.0 times ULN
- Serum creatinine ≤ 1.5 mg/dL
- Creatinine clearance > 50 mL/min
- No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No concurrent major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study participation
- No concurrent active infections
- No known HIV positivity
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior complete resection of all brain metastases
- No prior brain radiation therapy
- No prior temozolomide or erlotinib hydrochloride
- No concurrent enzyme-inducing anti-epileptic drugs
- No concurrent recombinant interleukin-11
- No other concurrent anticancer investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
- No concurrent enrollment on another clinical trial
- Surgery for symptomatic brain lesions prior to radiosurgery allowed
Sites / Locations
Outcomes
Primary Outcome Measures
Cognitive function
Secondary Outcome Measures
Tumor response
Time to tumor progression in brain
Survival
Quality of life as measured by FACT subscale
Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living
Frequency of O6-methylguanine-DNA methyltransferase promoter methylation
Full Information
NCT ID
NCT00385398
First Posted
October 5, 2006
Last Updated
August 29, 2013
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI), Schering-Plough, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00385398
Brief Title
QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
Official Title
Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding and drug supply
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI), Schering-Plough, Genentech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment.
PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.
Detailed Description
OBJECTIVES:
Primary
Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases.
Secondary
Determine the feasibility and safety of this regimen, in terms of tumor response, time to tumor progression in brain, survival, physical functioning, and quality of life, in these patients.
Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic radiosurgery on day -7. Patients receive oral temozolomide once daily on days 1-5 and oral erlotinib hydrochloride once daily on days 1-23. Treatment with temozolomide and erlotinib hydrochloride repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo cognitive function evaluation as measured by Mini-Mental Status Exam administration and scoring; quality of life assessment as measured by Functional Assessment of Cancer Therapy subscale; and physical functioning assessment as measured by Katz index of activities of daily living and Karnofsky performance status at baseline and then every 8 weeks during study treatment.
Tumor tissue is examined by O6-methylguanine-DNA methyltransferase (MGMT gene) promotor methylation.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Description
Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Description
Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Intervention Description
Stereotactic radiosurgery will be performed prior to chemotherapy.
Primary Outcome Measure Information:
Title
Cognitive function
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Tumor response
Time Frame
2 years
Title
Time to tumor progression in brain
Time Frame
2 years
Title
Survival
Time Frame
2 years
Title
Quality of life as measured by FACT subscale
Time Frame
2 years
Title
Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living
Time Frame
2 years
Title
Frequency of O6-methylguanine-DNA methyltransferase promoter methylation
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer meeting the following criteria:
One to 3 brain metastases, meeting the following criteria:
No larger than 3 cm
Greater than 5 mm from the optic apparatus
Not involving the brainstem, pons, medulla, or midbrain
Stable systemic disease for the past 3 months
Less than 3 months since completion of primary treatment
Measurable CNS disease as defined by RECIST criteria
No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic evaluation
PATIENT CHARACTERISTICS:
Life expectancy ≥ 12 weeks
Karnofsky performance status 60-100%
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 3.0 times ULN
Serum creatinine ≤ 1.5 mg/dL
Creatinine clearance > 50 mL/min
No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No concurrent major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study participation
No concurrent active infections
No known HIV positivity
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior complete resection of all brain metastases
No prior brain radiation therapy
No prior temozolomide or erlotinib hydrochloride
No concurrent enzyme-inducing anti-epileptic drugs
No concurrent recombinant interleukin-11
No other concurrent anticancer investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
No concurrent enrollment on another clinical trial
Surgery for symptomatic brain lesions prior to radiosurgery allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly Gabel, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC
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