Clinical Trial: Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy

Brief Summary: This clinical trial is studying how well granisetron, aprepitant, and dexamethasone work in preventing nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or stage IV ovarian cancer. Granisetron patch, aprepitant and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy for stage II, stage III, or stage IV ovarian cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the frequency of chemotherapy-induced nausea and vomiting based on complete response (no vomiting and no use of rescue therapy) during the 6 days following intraperitoneal (IP) chemotherapy for the 3-day regimen of aprepitant (both injection and capsules) in combination with granisetron transdermal system and dexamethasone in ovarian cancer patients receiving IP cisplatin OR IP carboplatin.

SECONDARY OBJECTIVES:

I. To evaluate possible endpoints for the chemotherapy-induced nausea and vomiting, including:

  • Functional Living Index-Emesis (FLIE) questionnaire scores
  • Mean vomiting, nausea and total FLIE scores and changes from baseline in FLIE scores
  • Percentages of patients with no impact on daily living (NIDL), i.e. > 108/126 total FLIE score II. To describe the timing of nausea and vomiting that may guide modifications to the standard regimen.

OUTLINE: This is a multicenter study.

Patients apply one patch of granisetron transdermal system to the upper outer arm on day 0 (at least 24 hours before intraperitoneal [IP] platinum therapy). Patients then receive dexamethasone orally (PO) on days 1-4, aprepitant IV over 15 minutes on day 1 (30 minutes before IP platinum therapy), and aprepitant PO on days 2-3.

Patients complete the Functional Living Index--Emesis (FLIE) and a symptom diary at baseline and on days 3 and 6.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Frequency of complete control defined as no vomiting and no use of rescue medications (for nausea or emesis) based on the patient-completed symptom diary [ Time Frame: During the 6 days following chemotherapy ]

Original Primary Outcome: Complete control of chemotherapy-induced nausea and vomiting

Current Secondary Outcome:

  • Change in vomiting, nausea and total FLIE scores [ Time Frame: Baseline to day 6 ]
  • Frequency and severity of adverse effects as assessed by the NCI CTCAE v 4.0 [ Time Frame: Up to day 6 ]
  • Mean and standard deviation of vomiting, nausea, and total FLIE scores [ Time Frame: Baseline ]
  • Percentages of patients with NIDL based on FLIE [ Time Frame: Up to day 6 ]


Original Secondary Outcome:

  • Mean of patients with vomiting, nausea, and total Functional Living Index--Emesis (FLIE) scores
  • Percentages of patients with no impact on daily living (NIDL) based on FLIE
  • Quality of life based on FACT-O
  • Frequency and severity of adverse effects as assessed by the NCI CTCAE v 4.0


Information By: Gynecologic Oncology Group

Dates:
Date Received: January 11, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017