Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)
Palonosetron is a drug that is designed to prevent and treat nausea and vomiting that is
caused by chemotherapy.
If you are found to be eligible to take part in this study, you will have several blood
samples taken (about 3 teaspoons each). Researchers will use the samples to monitor blood
counts during chemotherapy and periods of myelosuppression (a condition in which bone marrow
activity is decreased). These blood samples will be taken at least 2 times a week, and at
certain times, they will be taken once a day. You will be asked to fill out a QOL
questionnaire about nausea and vomiting, at least 2 times during Cycle 1 (one cycle lasts 21
days). It will take about 10 minutes to complete the questionnaire.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.
Participants in one group will receive one dose of palonosetron on Day 0. Participants in
the other group will receive 3 doses of palonosetron on Days 0, 2, and 4. Palonosetron will
be given to participants in both groups, as an intravenous (IV--through a needle in your
vein) infusion over 30 minutes.
You will be asked to keep a study diary during the treatment period. Study personnel will
give you the diary and tell you how to complete it. Your side effects (including how severe
they are) and medication doses need to be recorded in your diary every day. You will be
asked to return your diary at each post-treatment return visit (about every 3 weeks).
While you are on this study, you will receive chemotherapy as part of your standard
treatment. All participants will receive at least 2 cycles of adriamycin and ifosfamide
chemotherapy (AI). A cycle is 3 weeks long. You may receive up to 6 cycles of adriamycin
and ifosfamide. Adriamycin will be given as one large injection through a central venous
catheter (plastic tube and needle placed under the collarbone) on Day 0. Ifosfamide will be
given over 3 hours every day for 4 days (Days 0-3). Zinecard will be given as one large
injection through the catheter on Day 0. Mesna will be given as a 24-hour infusion every
day for 4 days through the same catheter (Days 0-3). Zinecard and mesna are given as
standard of care. Zinecard is used to protect against heart-related side effects. Mesna is
used to protect against bladder-related side effects. For patients with certain types of
sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only.
You may be treated as an outpatient or an inpatient. You will be asked to return to M.
D.Anderson every 3 weeks for evaluation of your disease, by having a chest x-ray, a
computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, and a physical
exam performed. Additional blood samples (about 3 teaspoons) will be taken before each cycle
and as often as needed to measure your blood counts and electrolytes (minerals in the body)
to monitor any imbalances.
You will be asked to contact the study doctor or nurse about any bad side effects you
experience or any medications (over-the-counter or prescription) you take during the
treatment period. You will also be asked to notify your other doctors (separate from the
study doctors) that you are participating in this research study.
Your treatment will continue for at least 6 cycles, unless your disease gets worse or you
experience intolerable side effects. If you experience any intolerable side effects or your
disease gets worse while on this study, you may be taken off this study.
Once you stop treatment, you will have what is called an end-of-study visit. During this
visit, you will be evaluated for your disease status with CT and MRI scans. You will have
your vital signs and weight measured. You will be asked about any medications you have
taken since your last visit and any bad side effects that you have experienced. You will
also have a final blood draw (about 3 teaspoons) for routine tests.
Your participation in this study should end at about 18 weeks (4 to 5 months).
Once you go off this study, you will have standard follow-up as is required by your doctor.
This is an investigational study. Palonosetron is FDA approved and is commercially
Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Palonosetron Response Rate in the 10 Day Study Cycle
Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.
Saroj Vadhan-Raj, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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