Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Procedure: Whole brain radiotherapy
- Registration Number
- NCT00266812
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
- 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 g/dL.
- 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 acceptable.
- 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 temozolomide.
- Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
- Surgery within two weeks prior to temozolomide administration.
- Recursive Partitioning Analysis (RPA) class III
- Patients with a single brain metastasis amenable to radiosurgery of resection
- Known Human Immunodeficiency Virus (HIV) disease.
- Acute infection requiring intravenous antibiotics.
- Any reason making compliance to the protocol improbable.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy with temozolomide and radiotherapy Temozolomide and radiotherapy - Radiotherapy alone Whole brain radiotherapy -
- Primary Outcome Measures
Name Time Method Number of Participants With Progression-free Survival (6 Month) 6 months The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as \<25% increase in tumor size on CT or MRI.
- Secondary Outcome Measures
Name Time Method