Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410488
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2006-12-11
Brief Title:
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide AI
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
DoseSchedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide AI
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to compare 2 treatment schedules of Aloxi palonosetron in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide The safety of the drug and schedules will be studied The effect of palonosetron on patients quality of life QOL will also be studied
Detailed Description:
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 DAnderson 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 available
Up to 50 patients will take part in this study All will be enrolled at M D Anderson
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 DAnderson 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 available
Up to 50 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None