Status:
TERMINATED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
AESCA Pharma GmbH
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00266812
Start Date
March 8 2005
End Date
January 16 2008
Last Update
June 8 2017
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