QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC

NCT ID: NCT00385398

Last Updated: 2013-09-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-12-31

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.

Conditions

Lung Cancer; Metastatic Cancer

Keywords

tumors metastatic to brain; stage IV non-small cell lung cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

erlotinib hydrochloride

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

temozolomide

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: DRUG

stereotactic radiosurgery

Stereotactic radiosurgery will be performed prior to chemotherapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Molly Gabel, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0220060108

Identifier Type: OTHER

Identifier Source: secondary_id

CINJ-NJ1506

Identifier Type: -

Identifier Source: secondary_id

CDR0000539474

Identifier Type: -

Identifier Source: secondary_id

030601

Identifier Type: -

Identifier Source: org_study_id