Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
Chemotherapy-related nausea and vomiting is a frequent problem among patients with leukemia that can lead to further medical problems, such as malnutrition, dehydration, electrolyte imbalance, and a lower quality of life. Cytarabine, one of the drugs that is used to treat AML and high-risk MDS, is known to cause nausea and/or vomiting, so all patients that receive chemotherapy with cytarabine also need to receive medication to prevent these side effects.
One standard-of-care drug to treat chemotherapy-related nausea and vomiting is called Ondansetron. Palonosetron is a new drug similar to Ondansetron that is designed to stay longer in the bloodstream. Researchers want to find out if palonosetron can prevent nausea and vomiting better than ondansetron.
Women who are able to have children must have a negative blood or urine pregnancy test before starting treatment.
If you are still eligible to take part in this study, you will be randomly assigned (as in the roll of the dice) to one of 3 treatment groups. Participants in the first group will be given Ondansetron as an intravenous (IV--through a needle in your vein) continuous infusion, from 30 minutes before your chemotherapy treatment until 12 hours after chemotherapy ends. This is considered the standard of care.
Participants assigned to the second treatment group will be given palonosetron once a day by IV injection for 5 days. Each dose will be given over a period of 30 seconds, 30 minutes before your chemotherapy treatment.
Participants assigned to the third treatment group will be given palonosetron once a day by IV injection, on Days 1, 3, and 5 of chemotherapy treatment. Each dose will be given over a period of 30 seconds, 30 minutes before your chemotherapy treatment.
No matter what group you are assigned to, you will receive extra medication for nausea and/or vomiting as needed.
You will be asked to fill out a study diary daily for 7 days, and it should take you no longer than 10 minutes to complete. The diary will be used to record the number of episodes of nausea and/or vomiting you experience during this study, as well as to record any need for extra medications, and to help researchers learn which of the 2 drugs helps the best to improve participants' quality of life (such as sleep, daily activities, and your ability to think and reason).
You will be taken off study if intolerable side effects occur.
This is an investigational study. The Food and Drug Administration (FDA) has approved palonosetron and Ondansetron for the prevention of chemotherapy-related nausea and vomiting, and both drugs are commercially available. Up to 150 participants will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron: Standard of Care | Active Comparator | Standard of care, Ondansetron 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. |
|
| Palonosetron Group 1 (5 Days) | Experimental | Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy treatment. |
|
| Palonosetron Group 2 (3 Days) | Experimental | Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy treatment, given over 30 seconds, 30 minutes before chemotherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complete Response | Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy. | 7 days, starting first day of chemotherapy |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jorge Cortes, MD | UT MD Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center website | View source |
Not provided
Of the 150 enrolled, only 143 patients were evaluable. Two patients were transferred to intensive care unit, two patients did not receive chemotherapy. One patient received one dose and was placed on hold. One patient received two antiemetic drugs; and 1 patient had a severe headache after two doses and was withdrawn.
Recruitment Period: 9/13/2005 to 9/22/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ondansetron: Standard of Care | Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. |
| FG001 | Palonosetron Group 1 (5 Days) | Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy. |
| FG002 | Palonosetron Group 2 (3 Days) | Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ondansetron: Standard of Care | Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. |
| BG001 | Palonosetron Group 1 (5 Days) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Complete Response | Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy. | Analysis was per protocol. Seven patients were excluded from the efficacy analysis. | Posted | Number | participants | 7 days, starting first day of chemotherapy |
|
3 years and 7 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ondansetron: Standard of Care | Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (2.0) | Systematic Assessment | Death is due to disease progression and is unrelated to study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Cortes, MD / Professor | UT MD Anderson Cancer Center | 713-745-5783 | eharrison@mdanderson.org |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D014839 | Vomiting |
| D009325 | Nausea |
| D007938 | Leukemia |
| D019337 | Hematologic Neoplasms |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Palonosetron | Drug | Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy. Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on Days 1, 3, and 5 of cytarabine chemotherapy, 30 minutes before chemotherapy. |
|
|
Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
| BG002 | Palonosetron Group 2 (3 Days) | Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Palonosetron Group 1 (5 Days) | Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy. |
| OG002 | Palonosetron Group 2 (3 Days) | Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy. |
|
|
| 6 |
| 49 |
| 2 |
| 49 |
| EG001 | Palonosetron Group 1 (5 Days) | Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy. | 2 | 51 | 9 | 51 |
| EG002 | Palonosetron Group 2 (3 Days) | Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy. | 4 | 50 | 11 | 50 |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Renal Failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Headache | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Infection Sepsis | Infections and infestations | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Bradycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Alanine Aminotransferase | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Febrile Neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Hyperbilirubinemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment | Unrelated to study drug |
|
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D012817 |
| Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |