Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)
Phase 2
Completed
- Conditions
- Metastases of Central Nervous SystemMelanomaBreast NeoplasmCarcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT00831545
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If \>=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if \>=10 patients will respond. If \<2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
Inclusion Criteria
- Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
- Brain metastases >=1 cm presenting or in progression following >=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
- Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
- Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
- Age <=70 years.
- Performance status 0-2 (ECOG-WHO scale).
- Blood leukocytes >=3.5 x 10^9/L and platelets >=100 x 10^9/L.
- Bilirubin <=25 M/L.
- Seric transaminases <=2 x upper limit of normal values.
- Creatinine <=150 M/L, creatinine clearance >=60 mL/min.
- Signed written informed consent.
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Exclusion Criteria
- Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
- Previous whole brain irradiation.
- Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
- 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.
- Pregnant or nursing women.
- Acute infection requiring intravenous antibiotics.
- Severe vomiting or medical condition which could interfere with oral medication intake.
- Anticonvulsant chronic therapy.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects with non-small cell lung cancer Temozolomide - Subjects with breast cancer Temozolomide - Subjects with melanoma Temozolomide -
- Primary Outcome Measures
Name Time Method Best response related to brain metastases observed during the study period. After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks.
- Secondary Outcome Measures
Name Time Method Progression-free survival, brain progression-free survival, and overall survival. After 2 months of initial treatment. If response or stable disease evaluations were performed every 3 months. Subsequently, an additional check up was added by amendment: a follow up check was performed after 4 weeks. Adverse events according to NCI CTC grading system of toxicity. Throughout the study.