SarcomaNCT01490060
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen
A study testing Fosaprepitant, Dexamethasone and 5HT3 receptor antagonist in people with Sarcoma and Chemotherapy-induced Nausea and Vomiting, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sarcoma, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy
- What is being tested?
- Fosaprepitant, Dexamethasone and 5HT3 receptor antagonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and vincristine (VAI) is indicated.
- Must be 18-65 years of age.
- Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
- Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 x normal and SGOT or SGPT </= 3 x normal) functions.
- Karnofsky Performance Status >/= 60%
- Signed informed consent form.
- Patients are required to read and understand English to comply with protocol requirements.
Who cannot join
- Pregnant or lactating women.
- Patients with any co-morbid condition which renders patients at high risk of treatment complication.
- Known allergy to fosaprepitant or any of its active components.
- Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months.
- Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years).
- Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
- Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
- Patients receiving any medication for pre-existing nausea/vomiting will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-3722
About this study
Official title: Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen
The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied.
Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will receive fosaprepitant during 21-day chemotherapy cycles. You will be randomly assigned (as in a toss of dice) to 1 of 2 study groups, each with 2 divisions:
- If you are in Group A1, you will receive fosaprepitant on Day 1 of Cycle 1.
- If you are in Group A2, you will receive fosaprepitant on Day 1 of Cycle 2.
- If you are in Group B1, you will receive fosaprepitant on Days 1 and 4 of Cycle 1.
- If you are in Group B2, you will receive fosaprepitant on Days 1 and 4 Cycle 2.
You and the study staff will know to which group and division you are assigned. Each time you receive the drug, you will receive it by vein over about 20-30 minutes.
You will also receive the ifosfamide-based chemotherapy prescribed by your doctor, as well as standard drugs for preventing nausea and vomiting (such as ondansetron, lorazepam, diphenhydramine, and promethazine). You will sign a separate consent form that will describe these treatments in detail, along with their risks.
You will receive dexamethasone before chemotherapy, every day for 5 days, to help prevent nausea and vomiting.
Before each chemotherapy cycle, you will be given a study diary. Each day, you will record any side effects you may . You should bring your study diary to every study visit so the study staff can review it.
Study Visits:
Before each cycle that you receive fosaprepitant, the following tests and procedures will be performed:
- You will have a physical exam.
- Your vital signs, weight, and performance status will be recorded.
- You will fill out the same questionnaire you did at screening.
- You will be asked about any other drugs you may be taking. Be sure to tell the study doctor about all drugs (including vitamins, herbal products, and nutritional supplements), because some drugs/substances will cause side effects when taken at the same time as fosaprepitant.
- Blood (about 5 teaspoons) will be drawn for routine tests.
Blood (about 1 teaspoon) will also be drawn 2 times each week during Cycles 1 and 2 for routine tests.
Pharmacokinetic Testing:
On Days 1 and 4 of Cycles 1 and 2 of chemotherapy, blood samples (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing, when possible. PK testing measures the amount of study drug in the body at different time points. The blood will be drawn before you receive ifosfamide, at the end of the infusion, and 4 more times in the 24 hours after the infusion.
Length of Study:
You may receive up to 6 cycles of chemotherapy (and up to 5 cycles of fosaprepitant). You will no longer be able to take the study drug if the disease gets worse or if intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 3 weeks after your last dose of fosaprepitant, you will return for an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- Your vital signs, weight, and performance status will be recorded.
- You will fill out the same questionnaire you did at screening.
- You will be asked about any other drugs you may be taking.
- Blood (about 5 teaspoons) will be drawn for routine tests.
This is an investigational study. Fosaprepitant is FDA approved and commercially available in combination with other drugs for the prevention of nausea and vomiting that may be caused by chemotherapy. It is investigational to study how fosaprepitant may affect the drug levels of ifosfamide in the blood and how many doses should be given.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Sarcoma, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy, Adverse Effects of Medical Drugs
- Being tested
- Fosaprepitant, Dexamethasone, 5HT3 receptor antagonist, Ifosfamide-based chemotherapy (AI), Doxorubicin
- Keywords
- cancer, fosaprepitant, Ifosfamide-based Multi-day Chemotherapy, Chemotherapy-induced nausea and vomiting, CINV, multi-day chemotherapy regimens, antiemetics, adverse effect, doxorubicin plus ifosfamide, AI, AI and vincristine, VAI, aprepitant, prevention, nausea, vomiting, emetogenic chemotherapy
- Medical subject headings
- Sarcoma, Vomiting, Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosaprepitantDrug
Also called Fosaprepitant Dimeglumine
150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.
DexamethasoneDrug
Also called Dexamethasone acetate, Decadron
Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)
5HT3 receptor antagonistDrug
5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy
Ifosfamide-based chemotherapy (AI)Drug
Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.
DoxorubicinDrug
Also called Rubex, Adriamycin, Adriamycin RDF, Adriamycin PFS
25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy.
MesnaDrug
Also called Mesnex
Prior to ifosfamide (Day 1) - 500 mg/m^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m^2. The mesna infusion complete 24 hours after last dose of ifosfamide.
IfosfamideDrug
Also called Ifex
2.5 g/m^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m^2).
VincristineDrug
2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Day 1 | Experimental | Arm 1, Single Dose: Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 or Day 1 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy. Receives: Drug: Fosaprepitant; Drug: Dexamethasone; Drug: 5HT3 receptor antagonist; Drug: Ifosfamide-based chemotherapy (AI); Drug: Doxorubicin; Drug: Mesna; Drug: Ifosfamide; Drug: Vincristine |
| Two Doses Day 1 + Day 4 | Experimental | Arm 2, Two Doses: Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 or Day 1 + Day 4 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy. Receives: Drug: Fosaprepitant; Drug: Dexamethasone; Drug: 5HT3 receptor antagonist; Drug: Ifosfamide-based chemotherapy (AI); Drug: Doxorubicin; Drug: Mesna; Drug: Ifosfamide; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.
Measured: From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490060
- Sponsor's protocol ID
- 2011-0620
- Other IDs
- NCI-2012-00011
- Status last verified
- Mar 2016
- First submitted
- 8 Dec 2011
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT01490060
- Acronym / sponsor ID
- 2011-0620
- Conditions
- Sarcoma, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy, Adverse Effects of Medical Drugs
- Keywords
- cancer, fosaprepitant, Ifosfamide-based Multi-day Chemotherapy, Chemotherapy-induced nausea and vomiting, CINV, multi-day chemotherapy regimens, antiemetics, adverse effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Posted 3 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied.
Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will receive fosaprepitant during 21-day chemotherapy cycles. You will be randomly assigned (as in a toss of dice) to 1 of 2 study groups, each with 2 divisions:
- If you are in Group A1, you will receive fosaprepitant on Day 1 of Cycle 1.
- If you are in Group A2, you will receive fosaprepitant on Day 1 of Cycle 2.
- If you are in Group B1, you will receive fosaprepitant on Days 1 and 4 of Cycle 1.
- If you are in Group B2, you will receive fosaprepitant on Days 1 and 4 Cycle 2.
You and the study staff will know to which group and division you are assigned. Each time you receive the drug, you will receive it by vein over about 20-30 minutes.
You will also receive the ifosfamide-based chemotherapy prescribed by your doctor, as well as standard drugs for preventing nausea and vomiting (such as ondansetron, lorazepam, diphenhydramine, and promethazine). You will sign a separate consent form that will describe these treatments in detail, along with their risks.
You will receive dexamethasone before chemotherapy, every day for 5 days, to help prevent nausea and vomiting.
Before each chemotherapy cycle, you will be given a study diary. Each day, you will record any side effects you may . You should bring your study diary to every study visit so the study staff can review it.
Study Visits:
Before each cycle that you receive fosaprepitant, the following tests and procedures will be performed:
- You will have a physical exam.
- Your vital signs, weight, and performance status will be recorded.
- You will fill out the same questionnaire you did at screening.
- You will be asked about any other drugs you may be taking. Be sure to tell the study doctor about all drugs (including vitamins, herbal products, and nutritional supplements), because some drugs/substances will cause side effects when taken at the same time as fosaprepitant.
- Blood (about 5 teaspoons) will be drawn for routine tests.
Blood (about 1 teaspoon) will also be drawn 2 times each week during Cycles 1 and 2 for routine tests.
Pharmacokinetic Testing:
On Days 1 and 4 of Cycles 1 and 2 of chemotherapy, blood samples (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing, when possible. PK testing measures the amount of study drug in the body at different time points. The blood will be drawn before you receive ifosfamide, at the end of the infusion, and 4 more times in the 24 hours after the infusion.
Length of Study:
You may receive up to 6 cycles of chemotherapy (and up to 5 cycles of fosaprepitant). You will no longer be able to take the study drug if the disease gets worse or if intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
About 3 weeks after your last dose of fosaprepitant, you will return for an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- Your vital signs, weight, and performance status will be recorded.
- You will fill out the same questionnaire you did at screening.
- You will be asked about any other drugs you may be taking.
- Blood (about 5 teaspoons) will be drawn for routine tests.
This is an investigational study. Fosaprepitant is FDA approved and commercially available in combination with other drugs for the prevention of nausea and vomiting that may be caused by chemotherapy. It is investigational to study how fosaprepitant may affect the drug levels of ifosfamide in the blood and how many doses should be given.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose Day 1 | Experimental | Drug: Fosaprepitant, Drug: Dexamethasone, Drug: 5HT3 receptor antagonist, Drug: Ifosfamide-based chemotherapy (AI), Drug: Doxorubicin, Drug: Mesna, Drug: Ifosfamide, Drug: VincristineArm 1, Single Dose: Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 or Day 1 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy. |
| Two Doses Day 1 + Day 4 | Experimental | Drug: Fosaprepitant, Drug: Dexamethasone, Drug: 5HT3 receptor antagonist, Drug: Ifosfamide-based chemotherapy (AI), Drug: Doxorubicin, Drug: Mesna, Drug: Ifosfamide, Drug: VincristineArm 2, Two Doses: Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 or Day 1 + Day 4 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and vincristine (VAI) is indicated.
- Must be 18-65 years of age.
- Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
- Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 x normal and SGOT or SGPT </= 3 x normal) functions.
- Karnofsky Performance Status >/= 60%
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Patients with any co-morbid condition which renders patients at high risk of treatment complication.
- Known allergy to fosaprepitant or any of its active components.
- Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months.
- Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FosaprepitantAlso: Fosaprepitant Dimeglumine150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm. | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| DexamethasoneAlso: Dexamethasone acetate, DecadronIntravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| 5HT3 receptor antagonist5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| Ifosfamide-based chemotherapy (AI)Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc. | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| DoxorubicinAlso: Rubex, Adriamycin, Adriamycin RDF, Adriamycin PFS25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy. | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| MesnaAlso: MesnexPrior to ifosfamide (Day 1) - 500 mg/m^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m^2. The mesna infusion complete 24 hours after last dose of ifosfamide. | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| IfosfamideAlso: Ifex2.5 g/m^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m^2). | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
| Vincristine2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology. | Drug | Single Dose Day 1, Two Doses Day 1 + Day 4 |
Primary outcome
Complete Response
Time frame: From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).
Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fosaprepitant, Dexamethasone and 5HT3 receptor antagonist in people with Sarcoma and Chemotherapy-induced Nausea and Vomiting, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.