Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced NSCLC Patients With CNS Metastasis Versus Radiotherapy Alone
- Prior histologic confirmation of non-small cell lung cancer (NSCLC).
- Optional: NSCLC histologic confirmation of metastasis of NSCLC.
- Presence of unidimensionally measurable disease in the brain.
- No previous or current malignancies at other sites with the exception of adequately
treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
- Age: >18 years.
- Subjects must not have systemic disease that in the opinion of the investigator is in
immediate need of chemotherapy
- Karnofsky Performance status >=70%.
- Absolute neutrophil count (ANC) >1,500/mm^3, platelets >100,000/mm^3, hemoglobin >8
- Serum creatinine and bilirubin <1.5 times upper normal limit of testing laboratory.
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase
(SGPT) <3 times upper limit of testing laboratory.
- Palliative radiation therapy to thorax and bone or other organs (except brain) is
- Prior neurosurgery >2 weeks from initiating treatment with temozolomide.
- Cortisone medication stable or decreasing within 2 weeks prior to initiating
treatment with temozolomide.
- Patient is not pregnant or nursing and is advised and willing to use an effective
method of contraception.
- Written informed consent.
- Chemotherapy or biologic therapy within four weeks prior to initiating therapy with
- Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
- Surgery within two weeks prior to temozolomide administration.
- RPA class III
- Patients with a single brain metastasis amenable to radiosurgery of resection
- Known HIV disease.
- Acute infection requiring intravenous antibiotics.
- Any reason making compliance to the protocol improbable.