Clinical trial NCT00266812: 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)
Official title: Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Central Nervous System (CNS) Metastasis Versus Radiotherapy Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: temozolomide
radiotherapy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: AESCA Pharma GmbH
First posted: 2005-12-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Progression-free Survival (6 Month)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: