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)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Temozolomide and radiotherapy; Whole brain radiotherapy
Intervention description: Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).; 2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: temozolomide; radiotherapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.