Locally Advanced SarcomaPhase 2NCT02732015
Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy
A Phase 2 study testing Dexamethasone, Doxorubicin and Fosaprepitant Dimeglumine in people with Locally Advanced Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Sarcoma
- What is being tested?
- Dexamethasone, Doxorubicin and Fosaprepitant Dimeglumine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2016to 10 Jul 2020
- Phase
- Phase 2
- 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
- Patient must have an estimated life expectancy >= 4 months in the opinion of the investigators
- 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, use of an intrauterine device (IUD) or abstinence
- Female patients must have a negative pregnancy test at screening
- Female patients of childbearing potential must agree to use an acceptable method of birth control (excluding hormonal birth control methods) for 72 hours prior to admission and to continue its use during the study and for at least 30 days after the final dose
- Male patients must agree to use an acceptable form of birth control from study day 1 through at least 30 days after the final dose
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- Absolute neutrophil count (ANC) > 1500/mm^3
- Platelet count > 100,000/mm^3
- Serum creatinine < 1.5 mg/dL
- Serum bilirubin count < 1.5 x upper limit normal (ULN)
- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN; for subjects with known liver metastases < 5 x ULN
- Karnofsky performance status > 60%
- Signed informed consent form
- Patients are required to read and understand English to comply with protocol requirements
Who cannot join
- Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
- Patient has a known hypersensitivity to the administration of any prescribed oral or intravenous study medication or metabolite, including but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection
- Patient is a woman with a positive urine or serum pregnancy test within 3 days prior to study drug administration, is breast-feeding, or is planning to conceive children within the projected duration of the study treatment
- Patient has taken the anti-emetic agents within the last 48 hours prior to the start of treatment with study drug:
- 5-hydroxytryptamine (HT)3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product
- Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.)
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- Benzamides (metoclopramide, alizapride, etc.)
- Domperidone
- Cannabinoids
- Neurokinin (NK)1 antagonist (aprepitant)
- Benzodiazepines (lorazepam, alprazolam, etc)
- Herbal medications or preparations in doses designed to ameliorate nausea or emesis
- Patient has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of day 1 of the study except as premedication for chemotherapy (e.g., taxanes); subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled
- Patient has symptomatic primary or metastatic central nervous system (CNS) disease
- Patient has ongoing vomiting, retching, dry heaves, or clinically significant nausea caused by any etiology, or has had such symptoms within 24 hours prior to the start of day 1 of the study intervention, or has a history of anticipatory nausea and vomiting
- Patient must not have been dosed with test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose
- Patient who is participating in any investigational agent that is not Food and Drug Administration (FDA)-approved
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI)
This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the effect of rolapitant hydrochloride (rolapitant) on nausea/vomiting in patients with sarcoma receiving multi-day highly emetogenic chemotherapy (HEC) regimen of doxorubicin and ifosfamide (AI).
SECONDARY OBJECTIVES:
- To evaluate the toxicity of rolapitant in patients receiving AI regimen. II. To evaluate the effects of rolapitant on patient reported outcomes.
OUTLINE:
PART I: Patients receive dexamethasone intravenously (IV) daily and ondansetron IV on days 1-5, and rolapitant hydrochloride orally (PO) on day 1.
PART II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.
- Conditions
- Locally Advanced Sarcoma
- Being tested
- Dexamethasone, Doxorubicin, Fosaprepitant Dimeglumine, Ifosfamide, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given IV
DoxorubicinDrug
Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given IV
Fosaprepitant DimeglumineDrug
Also called Emend for Injection, L-785,298, MK-0517
Given IV
IfosfamideDrug
Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
MesnaDrug
Also called 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna
Given IV
OndansetronDrug
Also called Zofran ODT, Zuplenz
Given IV
Questionnaire AdministrationOther
Ancillary studies
Rolapitant HydrochlorideDrug
Also called Rolapitant HCl, Rolapitant Hydrochloride Monohydrate, Rolapitant Monohydrochloride Monohydrate, SCH-619734
Given PO
Also called Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (rolapitant hydrochloride) | Experimental | Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities. Receives: Drug: Dexamethasone; Drug: Doxorubicin; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Drug: Mesna; Drug: Ondansetron; Other: Questionnaire Administration; Drug: Rolapitant Hydrochloride; Drug: Vincristine Sulfate |
| Arm II (fosaprepitant dimeglumine) | Active comparator | Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities. Receives: Drug: Dexamethasone; Drug: Doxorubicin; Drug: Fosaprepitant Dimeglumine; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Drug: Mesna; Drug: Ondansetron; Other: Questionnaire Administration; Drug: Vincristine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose
Complete response (CR) no emetic episodes and no rescue medications.
Measured: Days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start12 Oct 2016
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Why it stopped: Terminated per PI's request
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 Locally Advanced 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732015
- Sponsor's protocol ID
- 2015-0587
- Other IDs
- NCI-2016-00801, 2015-0587
- Status last verified
- Aug 2021
- First submitted
- 4 Apr 2016
- Last updated
- 9 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI)
- ClinicalTrials.gov ID
- NCT02732015
- Acronym / sponsor ID
- 2015-0587
- Conditions
- Locally Advanced Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated per PI's request
- Enrolment
- 37 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the effect of rolapitant hydrochloride (rolapitant) on nausea/vomiting in patients with sarcoma receiving multi-day highly emetogenic chemotherapy (HEC) regimen of doxorubicin and ifosfamide (AI).
SECONDARY OBJECTIVES:
- To evaluate the toxicity of rolapitant in patients receiving AI regimen. II. To evaluate the effects of rolapitant on patient reported outcomes.
OUTLINE:
PART I: Patients receive dexamethasone intravenously (IV) daily and ondansetron IV on days 1-5, and rolapitant hydrochloride orally (PO) on day 1.
PART II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (rolapitant hydrochloride) | Experimental | Drug: Dexamethasone, Drug: Doxorubicin, Drug: Ifosfamide, Other: Laboratory Biomarker Analysis, Drug: Mesna, Drug: Ondansetron, Other: Questionnaire Administration, Drug: Rolapitant Hydrochloride, Drug: Vincristine SulfatePatients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities. |
| Arm II (fosaprepitant dimeglumine) | Active comparator | Drug: Dexamethasone, Drug: Doxorubicin, Drug: Fosaprepitant Dimeglumine, Drug: Ifosfamide, Other: Laboratory Biomarker Analysis, Drug: Mesna, Drug: Ondansetron, Other: Questionnaire Administration, Drug: Vincristine SulfatePatients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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
- Patient must have an estimated life expectancy >= 4 months in the opinion of the investigators
- 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, use of an intrauterine device (IUD) or abstinence
- Absolute neutrophil count (ANC) > 1500/mm^3
- Platelet count > 100,000/mm^3
Key exclusion criteria (20 listed)
- Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
- Patient has a known hypersensitivity to the administration of any prescribed oral or intravenous study medication or metabolite, including but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection
- Patient is a woman with a positive urine or serum pregnancy test within 3 days prior to study drug administration, is breast-feeding, or is planning to conceive children within the projected duration of the study treatment
- Patient has taken the anti-emetic agents within the last 48 hours prior to the start of treatment with study drug:
- Patient has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of day 1 of the study except as premedication for chemotherapy (e.g., taxanes); subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled
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 |
|---|---|---|
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven IV | Drug | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| DoxorubicinAlso: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, HydroxyldaunorubicinGiven IV | Drug | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| Fosaprepitant DimeglumineAlso: Emend for Injection, L-785,298, MK-0517Given IV | Drug | Arm II (fosaprepitant dimeglumine) |
| IfosfamideAlso: Asta Z 4942, Asta Z-4942, Cyfos, HoloxanGiven IV | Drug | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| MesnaAlso: 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, FilesnaGiven IV | Drug | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| OndansetronAlso: Zofran ODT, ZuplenzGiven IV | Drug | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
| Rolapitant HydrochlorideAlso: Rolapitant HCl, Rolapitant Hydrochloride Monohydrate, Rolapitant Monohydrochloride Monohydrate, SCH-619734Given PO | Drug | Arm I (rolapitant hydrochloride) |
| Vincristine SulfateAlso: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, OncovinGiven IV | Drug | Arm I (rolapitant hydrochloride), Arm II (fosaprepitant dimeglumine) |
Primary outcome
Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose
Time frame: Days 1-10
Complete response (CR) no emetic episodes and no rescue medications.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- 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 principal investigator
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 Phase 2 study testing Dexamethasone, Doxorubicin and Fosaprepitant Dimeglumine in people with Locally Advanced Sarcoma, 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 14 inclusion and 20 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: stopped early, as of the sponsor's last update on 9 Aug 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2021). 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?
Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose (time frame: Days 1-10). 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 9 Aug 2021.