Ovarian CancerPhase 4NCT01432015
Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
A Phase 4 study testing fosaprepitant and aprepitant in people with Ovarian Cancer and Uterine Cancer, run by Gynecologic Oncology Associates at 1 site in United States.
Trial summary
Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Uterine Cancer
- What is being tested?
- fosaprepitant and aprepitant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2015
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Gender
- Age > 18 years
- A histologic diagnosis of stage III/IV gynecologic cancer (e.g., epithelial ovarian, fallopian tube, peritoneal cancer and uterine cancer).
- Subjects who will be treated with Taxol and Carboplatin as standard of care for a newly diagnosed gynecological cancer.
- Adequate bone marrow function as demonstrated by:
- Absolute neutrophil count (ANC) > 1,500/μL; platelet count > 100,000/μL; and hemoglobin > 9 g/dL • Adequate renal function demonstrated by: Serum creatinine of < 1.5 x ULN or 24-hr measured urine creatinine clearance > 60 mL/min for patients with serum creatinine > 1.5 x ULN
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- Adequate hepatic function demonstrated by: Total bilirubin of < 1.5 x ULN AST or ALT ≤ 2.5 x ULN
- EGOG status of < 2: Postoperatively, patients demonstrate an ECOG score of 1 or 2. However, during the first cycle of chemotherapy, the patients' performance status improves to < 1.
- Projected life expectancy of at least 3 months
- Ability to comply with the visit schedule and assessments required by the protocol
- Negative pregnancy test for women of childbearing potential
- Signed, IRB approved informed consent and HIPPA consent
Who cannot join
- Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas) are not eligible.
- Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone
- An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
- Subjects with concomitant malignancy or a previous malignancy within the past three (3) years (except non-melanoma skin cancer)
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- Screening clinical laboratory values of:
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- ANC of <1500/DL Platelet count of <100,000/µL Total bilirubin of 1.5 mg/dL x ULN SGOT (AST) or SGPT (ALT) 2.5 x ULN Serum creatinine of 1.5 mg/dL Hemoglobin of 9 gm/dL (may be transfused or receive a colony stimulating factor to maintain or exceed this level)
- EGOG status of > 2
- Gastrointestinal obstruction or an active peptic ulcer
- Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
- Known active HIV and viral hepatitis infections
- Inability to comply with study
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Associates
Newport Beach, California, 92663
About this study
Official title: A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer
Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.
Read the detailed description
Studies have indicated that oral and intravenous anti-emetics are equivalent with regard to efficacy; when evaluating cost and convenience, the intravenous route may be preferable. Fosaprepitant, a water-soluble phosphoryl prodrug for aprepitant, is converted to aprepitant via phosphatases following intravenous administration. Given the rapid conversion of fosaprepitant to the active form (i.e., aprepitant), the two medications appear to provide a similarly effective antiemetic impact. Clinical reports have additionally suggested that fosaprepitant could be appropriate as an intravenous alternative to the oral aprepitant.
- Conditions
- Ovarian Cancer, Uterine Cancer
- Being tested
- fosaprepitant, aprepitant, Oral Placebo, IV placebo
- Keywords
- aprepitant, fosaprepitant, gynecologic cancer, emesis
- Medical subject headings
- Ovarian Neoplasms, Uterine Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fosaprepitantDrug
Also called Emend IV
Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications
aprepitantDrug
Also called Emend
Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications
Oral PlaceboOther
One pill administered on days 1-3 in conjunction with Fosaprepitant.
IV placeboOther
Also called Normal Saline
100 cc of IV placebo administered on day in conjunction with Aprepitant
| Study group | Role | What they receive |
|---|---|---|
| Fosaprepitant | Active comparator | Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Oral Placebo given on days 1-3 Receives: Drug: fosaprepitant; Other: Oral Placebo |
| Aprepitant | Active comparator | Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1 Receives: Drug: aprepitant; Other: IV placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Complete Response Rate
no emetic episodes or rescue therapy following the initiation of chemotherapy
Measured: 13 months
Secondary outcomes (1)
Impact on Daily Living Activities
Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionMar 2015
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 Ovarian 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- John P Micha, MD, Principal investigator, Gynecologic Oncology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432015
- Sponsor's protocol ID
- GOA-NVM1
- Status last verified
- May 2015
- First submitted
- 7 Sep 2011
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer
- ClinicalTrials.gov ID
- NCT01432015
- Acronym / sponsor ID
- GOA-NVM1
- Conditions
- Ovarian Cancer, Uterine Cancer
- Keywords
- aprepitant, fosaprepitant, gynecologic cancer, emesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gynecologic Oncology AssociatesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 27 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.
Detailed description
Studies have indicated that oral and intravenous anti-emetics are equivalent with regard to efficacy; when evaluating cost and convenience, the intravenous route may be preferable. Fosaprepitant, a water-soluble phosphoryl prodrug for aprepitant, is converted to aprepitant via phosphatases following intravenous administration. Given the rapid conversion of fosaprepitant to the active form (i.e., aprepitant), the two medications appear to provide a similarly effective antiemetic impact. Clinical reports have additionally suggested that fosaprepitant could be appropriate as an intravenous alternative to the oral aprepitant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosaprepitant | Active comparator | Drug: fosaprepitant, Other: Oral PlaceboFosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Oral Placebo given on days 1-3 |
| Aprepitant | Active comparator | Drug: aprepitant, Other: IV placeboAprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. 100 cc of IV placebo administered on day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female Gender
- Age > 18 years
- A histologic diagnosis of stage III/IV gynecologic cancer (e.g., epithelial ovarian, fallopian tube, peritoneal cancer and uterine cancer).
- Subjects who will be treated with Taxol and Carboplatin as standard of care for a newly diagnosed gynecological cancer.
- Adequate bone marrow function as demonstrated by:
Key exclusion criteria (13 listed)
- Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers of low malignant potential (borderline carcinomas) are not eligible.
- Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone
- An episode of vomiting or retching within 24 hours before the start of the initial treatment with chemotherapy
- Subjects with concomitant malignancy or a previous malignancy within the past three (3) years (except non-melanoma skin cancer)
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
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: Emend IVFosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications | Drug | Fosaprepitant |
| aprepitantAlso: EmendAprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications | Drug | Aprepitant |
| Oral PlaceboOne pill administered on days 1-3 in conjunction with Fosaprepitant. | Other | Fosaprepitant |
| IV placeboAlso: Normal Saline100 cc of IV placebo administered on day in conjunction with Aprepitant | Other | Aprepitant |
Primary outcome
Overall Complete Response Rate
Time frame: 13 months
no emetic episodes or rescue therapy following the initiation of chemotherapy
1 secondary outcome
Impact on Daily Living Activities
Time frame: 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John P Micha, MD principal investigator
Gynecologic Oncology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fosaprepitant and aprepitant in people with Ovarian Cancer and Uterine Cancer, run by Gynecologic Oncology Associates 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 12 inclusion and 13 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 28 Mar 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 May 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?
Overall Complete Response Rate (time frame: 13 months). 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 28 Mar 2017.