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

18 Years
Not Enrolling
Fallopian Tube Cancer, Nausea and Vomiting, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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



- 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.


- To evaluate possible endpoints for the chemotherapy-induced nausea and vomiting,
including Functional Living Index-Emesis (FLIE) questionnaire scores.

- To evaluate mean vomiting, nausea, and total FLIE scores and changes from baseline in
FLIE scores.

- To evaluate the percentage of patients with no impact on daily living (NIDL) (i.e., >
108/126 total FLIE score).

- 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.

Inclusion Criteria


- Diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

- Stage II, III, or IV disease

- Enrolled on GOG-0252

- Scheduled to receive intraperitoneal (IP) platinum therapy comprising cisplatin
or carboplatin

- Patients must be enrolled on GOG-0272 ≥ 48 hours in advance of course 1
treatment of GOG-0252


- Able to read, understand, and write English

- Able to complete the assessments

- Able to comply with the anti-emetic therapy

- No known hypersensitivity to aprepitant (injectable or oral), granisetron, any of the
components of the patch, or dexamethasone

- No patients who, in the opinion of the treating physician, have a medical condition,
or currently take medications that are felt to contraindicate safe or effective
administration of the standard three-drug anti-emetic regimen used in this study


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Complete control of chemotherapy-induced nausea and vomiting

Safety Issue:


Principal Investigator

Steven C. Plaxe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego


United States: Federal Government

Study ID:




Start Date:

June 2011

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Nausea and Vomiting
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • nausea and vomiting
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • stage IIA primary peritoneal cavity cancer
  • stage IIB primary peritoneal cavity cancer
  • stage IIC primary peritoneal cavity cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Nausea
  • Vomiting
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms