Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
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.
Fallopian Tube Cancer
Nausea and Vomiting
Primary Peritoneal Cavity Cancer
Drug: granisetron transdermal system
Other: questionnaire administration
Procedure: adjuvant therapy
Procedure: management of therapy complications
|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|
- Complete control of chemotherapy-induced nausea and vomiting [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275664
|Study Chair:||Steven C. Plaxe, MD||University of California, San Diego|