NCT01432015

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 ovarian-cancer

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 27, 2015

Completed
Last Updated

March 28, 2017

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

September 7, 2011

Results QC Date

April 29, 2015

Last Update Submit

February 24, 2017

Conditions

Ovarian CancerUterine Cancer

Keywords

aprepitantfosaprepitantgynecologic canceremesis

Outcome Measures

Primary Outcomes (1)

  • Overall Complete Response Rate

    no emetic episodes or rescue therapy following the initiation of chemotherapy

    13 months

Secondary Outcomes (1)

  • Impact on Daily Living Activities

    13 months

Study Arms (2)

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

Drug: fosaprepitantOther: 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

Drug: aprepitantOther: IV placebo

Interventions

fosaprepitantDRUG

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

Also known as: Emend IV
Fosaprepitant
aprepitantDRUG

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

Also known as: Emend
Aprepitant
Oral PlaceboOTHER

One pill administered on days 1-3 in conjunction with Fosaprepitant.

Fosaprepitant
IV placeboOTHER

100 cc of IV placebo administered on day in conjunction with Aprepitant

Also known as: Normal Saline
Aprepitant

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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:
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsUterine NeoplasmsVomiting

Interventions

fosaprepitantAprepitantSaline Solution

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
John P. Micha, M.D.
Organization
Gynecologic Oncology Associates
Research@gynoncology.com
949-642-5165

Study Officials

  • John P Micha, MD

    Gynecologic Oncology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 12, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 28, 2017

Results First Posted

May 27, 2015

Record last verified: 2015-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)