BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
This study will investigate the effects and side effects of BAY 43-9006 in patients with
advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of
a new class of anticancer agents known as bi-aryl ureas.
Patients 18 years of age and older with NSCLC that has recurred or progressed after one
regimen of chemotherapy may be eligible for this study. Candidates are screened with a
medical history and physical examination; blood tests; tumor biopsy (see below); chest x-ray;
electrocardiogram; and imaging studies, including positron emission tomography-computed
tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below).
Participants take BAY 43-9006 by mouth twice a day, morning and evening. On the first and
15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies;
that is, a test of how the body handles the drug. For the test, blood is collected at
intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to
determine the drug's level in the bloodstream. Treatment with BAY 43-9006 continues until the
study doctor determines that the medication is not beneficial or the patient wishes to
withdraw from the study.
In addition to drug therapy, patients undergo the following tests and procedures:
- Physical examination every 4 weeks
- Blood pressure checks once a week during the first 4 weeks
- Blood tests every week
- CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate
the tumor's response to treatment. CT is an x-ray test that provides detailed pictures
of the inside of the body. It can be done from different angles, providing a
3-dimensional picture of the part of the body being studied and allowing the doctor to
see the location, nature, and extent of disease. MRI uses a powerful magnet and radio
waves instead of x-rays to produce accurate, detailed pictures of organs and tissues.
- PET-CT approximately every 8 weeks to look at how different parts of the body take up
and use glucose (a sugar nutrient). Because rapidly growing cells, such as tumors, use
more sugar than normal cells do, this test can be used to detect cancer. For the test,
the patient is given an injection of a sugar solution in which a radioactive tracer has
been attached to the sugar molecule. A special camera detects the radiation emitted by
the solution, and the resulting images show how much sugar is being used in various
parts of the body. PET-CT uses the PET scan in combination with standard CT in a machine
that does both tests.
- DCE-MRI after 2 weeks of treatment. This test uses MRI with a special non-radioactive
dye to examine blood flow in a certain part of the body.
- Tumor biopsy (optional) after 2 weeks of treatment. A biopsy is the surgical removal of
a small piece of tissue. The tumor biopsy is done either using a small bore needle under
CT guidance or by direct visualization using a laparoscope/thoracoscope. For the needle
biopsy, a needle is inserted through the skin and guided by CT into the tumor mass. For
the laparoscopy/thoracoscopy, the patient is sedated or asleep and small lighted tubes
are inserted into small holes made in the skin. The tumor is located and tissue
withdrawn.