Conditions: Lung Cancer
Keywords: TEMOZOLOMIDE Lung
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma.

As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.

Detailed description:

Arms:
arm 1: 75 mg/m2/day Temozolomide for 21 days (7 days off treatment). 28 day cycles. arm 2: 200 mg/m2/day Temozolomide for 5 days (23 days off treatment). 28 day cycles.

Interventions: intervention 1: Temozolomide intervention 2: Temozolomide
Intervention descriptions: intervention 1: Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 75 mg/m2/day. intervention 2: Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.

Protocol document: