Breast CancerNCT00293384
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
A study testing Aprepitant, Cyclophosphamide and Dexamethasone in people with Breast Cancer and Chronic Myeloproliferative Disorders, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor
- What is being tested?
- Aprepitant, Cyclophosphamide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Feb 2012
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide
- Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation
- No psychiatric illness or multi-system organ failure
- No nausea at baseline
PATIENT CHARACTERISTICS:
- SWOG performance status 0-2
- Fewer than 5 alcoholic drinks per day within the past year
- No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics
- No gastrointestinal obstruction or active peptic ulcer disease
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ 2 mg/dL
- No known hypersensitivity to any component of the study regimen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No unrelenting hiccups
PRIOR CONCURRENT THERAPY:
- No chronic therapeutic warfarin > 1 mg dose per day
- No other concurrent investigational agents
- No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride
- No concurrent illegal drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.
Secondary
- Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.
- Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.
- Identify side effects of the addition of aprepitant to this regimen in these patients.
OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone, followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- Aprepitant, Cyclophosphamide, Dexamethasone, Granisetron hydrochloride
- Keywords
- nausea and vomiting, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, atypical chronic myeloid leukemia, BCR-ABL negative, blastic phase chronic myelogenous leukemia, chronic eosinophilic leukemia, primary myelofibrosis, chronic myelomonocytic leukemia, chronic neutrophilic leukemia, chronic phase chronic myelogenous leukemia, de novo myelodysplastic syndromes, disseminated neuroblastoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Medical subject headings
- Breast Neoplasms, Myeloproliferative Disorders, Gestational Trophoblastic Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
Aprepitant 80mg once daily in the morning on days 2 and 3
CyclophosphamideDrug
Also called Cytoxan®, Neosar®
Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
DexamethasoneDrug
Also called Decadron, Diodex, Hexadrol, Maxidex
Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Granisetron hydrochlorideDrug
Also called KYTRIL®
Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | Experimental | Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Receives: Drug: Aprepitant; Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Granisetron hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Controlled Acute Vomiting
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
Measured: at 0-24 hours
Secondary outcomes (2)
Delayed Vomiting Controlled
Measured: at 25-120 hours
Toxicity Grade 3, 4, or 5
Measured: at 0-120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startOct 2004
- Primary completionJun 2009
- Study completionFeb 2012
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 Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Muneer Abidi, Barbara Ann Karmanos Cancer Institute
- Investigators
- Muneer H. Abidi, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293384
- Sponsor's protocol ID
- CDR0000456201
- Other IDs
- P30CA022453, WSU-D-2797, WSU-0504001728
- Status last verified
- Feb 2016
- First submitted
- 16 Feb 2006
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation
- ClinicalTrials.gov ID
- NCT00293384
- Acronym / sponsor ID
- CDR0000456201
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- nausea and vomiting, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 3 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.
Secondary
- Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.
- Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.
- Identify side effects of the addition of aprepitant to this regimen in these patients.
OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone, followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | Experimental | Drug: Aprepitant, Drug: Cyclophosphamide, Drug: Dexamethasone, Drug: Granisetron hydrochlorideDay 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AprepitantAlso: EmendAprepitant 80mg once daily in the morning on days 2 and 3 | Drug | Aprepitant, Dexamethasone, Cytoxan & Kytril |
| CyclophosphamideAlso: Cytoxan®, Neosar®Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes | Drug | Aprepitant, Dexamethasone, Cytoxan & Kytril |
| DexamethasoneAlso: Decadron, Diodex, Hexadrol, MaxidexDexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. | Drug | Aprepitant, Dexamethasone, Cytoxan & Kytril |
| Granisetron hydrochlorideAlso: KYTRIL®Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration. | Drug | Aprepitant, Dexamethasone, Cytoxan & Kytril |
Primary outcome
Proportion of Participants With Controlled Acute Vomiting
Time frame: at 0-24 hours
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
2 secondary outcomes
Delayed Vomiting Controlled
Time frame: at 25-120 hours
Toxicity Grade 3, 4, or 5
Time frame: at 0-120 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Muneer H. Abidi, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprepitant, Cyclophosphamide and Dexamethasone in people with Breast Cancer and Chronic Myeloproliferative Disorders, run by Barbara Ann Karmanos Cancer Institute 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?
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 15 Mar 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 Oct 2014). 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?
Proportion of Participants With Controlled Acute Vomiting (time frame: at 0-24 hours). 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 15 Mar 2016.