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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01275664
First received: January 11, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention
Fallopian Tube Cancer
Nausea and Vomiting
Ovarian Cancer
Primary Peritoneal Cavity Cancer
 Drug: aprepitant
Drug: carboplatin
Drug: cisplatin
Drug: dexamethasone
Drug: granisetron transdermal system
Other: questionnaire administration
Procedure: adjuvant therapy
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete control of chemotherapy-induced nausea and vomiting [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean of patients with vomiting, nausea, and total Functional Living Index--Emesis (FLIE) scores [ Designated as safety issue: No ]
  • Percentages of patients with no impact on daily living (NIDL) based on FLIE [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects as assessed by the NCI CTCAE v 4.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275664

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Steven C. Plaxe, MD University of California, San Diego
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01275664     History of Changes
Other Study ID Numbers: CDR0000692516, GOG-0272
Study First Received: January 11, 2011
Last Updated: December 14, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Nausea
Vomiting
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
 Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Cisplatin
Dexamethasone
Carboplatin
Dexamethasone acetate
Granisetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101

ClinicalTrials.gov processed this record on May 21, 2013