Irinotecan (Camptosar) in Patients With Advanced Sarcomas
- To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma.
- To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas|
- Efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma [ Time Frame: Four 3-week cycles (12 weeks) ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2003|
|Study Completion Date:||January 2012|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Irinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days
16 mg/m2 by vein Daily Over 1 Hour x 5 Days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509860
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert S. Benjamin, MD||M.D. Anderson Cancer Center|