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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00385398
• Other study ID #: 030601
• Secondary ID: P30CA07272002200
• Status: Withdrawn
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: August 29, 2013
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• erlotinib hydrochloride
Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.
• 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.

Radiation:
• stereotactic radiosurgery
Stereotactic radiosurgery will be performed prior to chemotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Genentech, Inc., National Cancer Institute (NCI), Schering-Plough

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function		2 years	No
Secondary	Tumor response		2 years	No
Secondary	Time to tumor progression in brain		2 years	No
Secondary	Survival		2 years	No
Secondary	Quality of life as measured by FACT subscale		2 years	No
Secondary	Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living		2 years	No
Secondary	Frequency of O6-methylguanine-DNA methyltransferase promoter methylation		2 years	No