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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Gynecologic Oncology Associates
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gynecologic Oncology Associates
ClinicalTrials.gov Identifier:
NCT01432015
First received: September 7, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Uterine Cancer
Drug: fosaprepitant including placebo
Drug: aprepitant including placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Associates:

Primary Outcome Measures:
  • Proportion of patients reporting no vomiting during the five days following initiation of chemotherapy [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall complete response rate (no emetic episodes or rescue therapy) during the five days (120 hours) following the initiation of chemotherapy [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fosaprepitant including placebo

Fosaprepitant (EMEND™) 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 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1

Aprepitant (EMEND™) is 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

Drug: fosaprepitant including placebo
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
Other Name: Emend IV
Active Comparator: Aprepitant including placebo
Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.
Drug: aprepitant including placebo
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
Other Name: Emend

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432015

Locations
United States, California
Gynecologic Oncology Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Katrina Lopez, CCRC    949-642-5165    katrinal@gynoncology.com   
Principal Investigator: John Micha, MD         
Sponsors and Collaborators
Gynecologic Oncology Associates
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: John P Micha, MD Gynecologic Oncology Associates
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Associates
ClinicalTrials.gov Identifier: NCT01432015     History of Changes
Other Study ID Numbers: GOA-NVM1
Study First Received: September 7, 2011
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Gynecologic Oncology Associates:
aprepitant
fosaprepitant
gynecologic cancer
emesis

Additional relevant MeSH terms:
Ovarian Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014