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

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: Genentech, Inc.; National Cancer Institute (NCI); Schering-Plough
• Treatments: Dacarbazine; Erlotinib Hydrochloride; Temozolomide

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