Carcinoma, Non-Small-Cell Lung Clinical Trial
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
Verified date | April 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Ministry for Health and Women |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 35 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. | AESCA Pharma GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Progression-free Survival (6 Month) | 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. | 6 months | No |
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