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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00221 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Sancuso | INDUSTRY |
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The goal of this clinical research study is to compare granisetron (when given through a patch) to ondansetron (when taken by mouth) for reducing nausea and vomiting in women with cervical, endometrial, or vaginal cancer having chemoradiation.
Granisetron and ondansetron are designed to help reduce nausea and vomiting.
Study Groups:
If you agree to take part in this study, and you are among the first 40 participants, you will have an equal chance of being in either group. If you enroll after that, you will have a higher chance (51%-100%) of being assigned to the group that had better results.
Study Drug Administration:
If you are in Group 1, you will receive ondansetron by vein at your first visit only, which is standard of care. Then, you will receive cisplatin by vein over about 1 hour as part of the chemoradiation. A granisetron patch will then be placed on your skin before the chemotherapy . The patch will be replaced every 7 days before the chemotherapy.
If you are in Group 2, you will receive ondansetron by vein before cisplatin. Then, you will receive cisplatin by vein over about 1 hour. Then you will take ondansetron by mouth with a cup of water (8 ounces) 3 times a day for 3 days. Ondansetron is a tablet that you can take with or without food and is best taken at least 30 minutes before eating.
Both groups will be given a study drug diary to record the times that you take the study drugs. You will also record any nausea or vomiting that you may have. You should bring the diary to each study visit. You should also bring your study drug bottles/packages to each study visit.
Study Visits:
The visits for this study will be at the same time as your chemoradiation therapy visits over 5 weeks.
You will complete 3 questionnaires at your study visits and then again 1 week after the last chemotherapy. The last questionnaires will be completed by phone. The questionnaires ask about how easy or difficult it is to use your assigned study drug, your level of nausea and vomiting, and your quality of life. It should take about 5 minutes to complete these questionnaires each time.
Length of Treatment:
You may continue using the study drug up to 5 weeks during your chemoradiation treatment. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over when you have completed 5 weeks of chemoradiation treatments.
This is an investigational study. Both granisetron and ondansetron are FDA approved and commercially available for the treatment of nausea and vomiting. It is investigational to compare these drugs administered in different ways.
Up to 150 patients will take part in this study. Up to 120 participants will take part at MD Anderson. Up to 30 will be enrolled at the Harris Health System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granisetron | Experimental | Group A: 34.3 mg of granisetron formulated in transdermal patch replaced every 7 days. Transdermal patch placed/replaced prior to the intravenous (IV) infusion of cisplatin. At cycle 1, participants receive IV granisetron prior to IV cisplatin and prior to administration of transdermal patch. |
|
| Ondansetron | Experimental | Group B: 8 mg of ondansetron orally thrice daily starting with cisplatin administration and continued for 72 hours after chemotherapy infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granisetron | Drug | 34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle | Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence. | Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle | The response rates to anti-emetic therapy (no emetic or retching episodes and no rescue medication use) in the acute (0-24 hours) phase. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael M. Frumovitz, MD, MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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76 participants signed consent, 1 participant did not receive treatment due to the study closure.
Recruitment period: March 2012 until June 2016. All the recruitment was done in a medical clinic setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Transdermal Granisetron | 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin. |
| FG001 | Arm 2: Oral Ondansetron |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2015 |
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| Ondansetron | Drug | 8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion. |
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| Questionnaires | Behavioral | Completion of 3 questionnaires at study visits taking about 5 minutes each time. |
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| Study Drug Diary | Behavioral | Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced. |
|
| Baseline, up to 24 hours post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks |
| Houston |
| Texas |
| 77030 |
| United States |
8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Transdermal Granisetron | 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin. |
| BG001 | Arm 2: Oral Ondansetron | 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle | Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response Rate to Anti Emetic Therapy 0-24 Hours Each Chemotherapy Cycle | The response rates to anti-emetic therapy (no emetic or retching episodes and no rescue medication use) in the acute (0-24 hours) phase. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, up to 24 hours post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks |
|
Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Transdermal Granisetron | 8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin. | 0 | 41 | 0 | 41 | 15 | 41 |
| EG001 | Arm 2: Oral Ondansetron | 8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles. | 0 | 34 | 0 | 34 | 12 | 34 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Frumovitz, Professor, Gyn Onc & Reproductive Med | UT MD Anderson Cancer Center | (713) 792-9599 | mfrumovitz@mdanderson.org |
| Dec 8, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| D017294 | Ondansetron |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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