A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas
Irinotecan is a chemotherapy drug that fights cancer by interfering with the cancer cells'
ability to divide and grow.
Before treatment starts, you will be asked questions about your health and have a complete
physical exam. You will have an electrocardiogram (ECG - a test that measures the
electrical activity of the heart). You will have computed tomography (CT) scans and x-rays
to check on the status of the disease. If your doctor feels it is necessary, you may also
have a magnetic resonance imaging (MRI). Women who are able to have children must have a
negative blood or urine pregnancy test.
During treatment, you will receive irinotecan by vein over one hour, once a day for 5 days
in a row. This will be followed by 2 days of no study drug treatment, then 5 more days of
treatment with irinotecan. This 12-day period will be followed by 9 days of rest (no study
drug). This 21-day period is called a cycle of therapy. You will continue to receive
treatment (cycles repeated) as long as the disease does not get worse or until maximal
shrinkage of the cancer. Treatment may be taken on an outpatient basis.
During treatment, you will have blood collected (1-2 teaspoons) once a week for routine
tests. At least once every cycle of treatment (3 weeks) you will have a physical exam and
be asked questions about you health.
After the first 2 cycles, the disease will be re-evaluated. You will have blood tests (1-2
teaspoons), x-rays, and CT scans. If your doctor feels it is necessary, you may also have a
MRI. This re-evaluation will be repeated every 4 cycles.
If the disease gets worse or you experience any intolerable side effects, you will be taken
off the study and your doctor will discuss other treatment options with you.
Your doctor may choose to follow up with long-term exams at his/her discretion.
This is an investigational study. Irinotecan is FDA approved and is commercially available.
Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma
Efficacy based on dose limiting toxicity (DLT). Unacceptable toxicity is defined as grade 3 or 4 nonhematologic toxicity, or if expressed by the patient as unacceptable despite the grade. Patients evaluated for toxicity at the end of each cycle.
Four 3-week cycles (12 weeks)
Robert S. Benjamin, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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