Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
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

January 11, 2011
December 14, 2011
June 2011
January 2012   (final data collection date for primary outcome measure)
Complete control of chemotherapy-induced nausea and vomiting [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01275664 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Quality of life based on FACT-O [ 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 ]
Not Provided
Not Provided
 
Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
Not Provided
January 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01275664
CDR0000692516, GOG-0272
Not Provided
Philip J. DiSaia, Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Steven C. Plaxe, MD University of California, San Diego
National Cancer Institute (NCI)
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP