Pazopanib to Treat Adults With Advanced Cancers and Varying Degrees of Liver Function
Status:
Completed
Trial end date:
2013-01-22
Target enrollment:
Participant gender:
Summary
Background:
- Pazopanib is an experimental drug that was designed to enter cancer cells and block the
activity of proteins that are important for cancer cell growth and survival.
- This is the first study in which pazopanib is given to patients with different degrees
of liver function. The safe dose for patients with normal liver function is already
known.
Objectives:
- To determine the safety and side effects of pazopanib given at different dose levels to
patients with cancer who have different degrees of liver function.
- To find out how much pazopanib is in the blood at specific times.
- To determine if pazopanib is effective in treating advanced cancer in patients with
different degrees of liver function.
Eligibility:
- Patients 18 years of age and older with an advanced solid tumor or lymphoma that cannot be
treated successfully with standard therapies and who have normal or abnormal liver function.
Design:
- Treatment:
- Patients are divided into 4 groups, based on their liver function. The first three
patients in each group receive a low dose of pazopanib. The next three in each group
receive a higher dose of pazopanib if no serious side effects were reported in the
previous three. The dose is increased in succeeding groups of three patients until the
maximum study dose is reached.
- Patients take pazopanib once a day by mouth in 21-day treatment cycles. Treatment
continues until the cancer worsens, the patient develops severe side effects, the
patient no longer wants to continue the study, or the doctor removes the patient from
the study for other reasons.
- Monitoring:
- Blood pressure: Patients monitor and record their blood pressure twice a day after
starting treatment.
- Blood tests: Patients have weekly routine blood tests. In addition, at week 3 of the
first cycle and again after the highest safe dose has been determined, several blood
samples are collected at frequent intervals to determine how the body handles the drug.
- Imaging studies: X-rays or scans or both are done to measure the extent of disease every
3 cycles.
- Physical examinations are done at periodic intervals.