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Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting

Primary Purpose

Ovarian Cancer, Uterine Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fosaprepitant
aprepitant
Oral Placebo
IV placebo
Sponsored by
Gynecologic Oncology Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring aprepitant, fosaprepitant, gynecologic cancer, emesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Gynecologic Oncology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fosaprepitant

Aprepitant

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Complete Response Rate
no emetic episodes or rescue therapy following the initiation of chemotherapy

Secondary Outcome Measures

Impact on Daily Living Activities
Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy

Full Information

First Posted
September 7, 2011
Last Updated
February 24, 2017
Sponsor
Gynecologic Oncology Associates
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01432015
Brief Title
Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Associates
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Uterine Cancer
Keywords
aprepitant, fosaprepitant, gynecologic cancer, emesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fosaprepitant
Arm Type
Active Comparator
Arm Description
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
Arm Title
Aprepitant
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
fosaprepitant
Other Intervention Name(s)
Emend IV
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
aprepitant
Other Intervention Name(s)
Emend
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Oral Placebo
Intervention Description
One pill administered on days 1-3 in conjunction with Fosaprepitant.
Intervention Type
Other
Intervention Name(s)
IV placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
100 cc of IV placebo administered on day in conjunction with Aprepitant
Primary Outcome Measure Information:
Title
Overall Complete Response Rate
Description
no emetic episodes or rescue therapy following the initiation of chemotherapy
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Impact on Daily Living Activities
Description
Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy
Time Frame
13 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Micha, MD
Organizational Affiliation
Gynecologic Oncology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting

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