Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01275664|
Recruitment Status : Terminated (Study terminated due to no patient population available)
First Posted : January 12, 2011
Results First Posted : April 12, 2018
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nausea and Vomiting Ovarian Brenner Tumor Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Cystadenocarcinoma Stage II Ovarian Cancer Stage IIA Fallopian Tube Cancer Stage IIA Ovarian Cancer Stage IIB Fallopian Tube Cancer Stage IIB Ovarian Cancer Stage IIC Fallopian Tube Cancer Stage IIC Ovarian Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Cancer Stage IIIA Primary Peritoneal Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Cancer Stage IIIB Primary Peritoneal Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IIIC Primary Peritoneal Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cancer Undifferentiated Ovarian Carcinoma||Procedure: Adjuvant Therapy Drug: Aprepitant Drug: Carboplatin Drug: Cisplatin Drug: Dexamethasone Drug: Granisetron Transdermal Patch Procedure: Management of Therapy Complications Other: Questionnaire Administration||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2014|
Experimental: Treatment (granisetron, dexamethasone, aprepitant)
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 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.
Procedure: Adjuvant Therapy
Given IV and PO
Drug: Granisetron Transdermal Patch
Apply one patch to upper arm
Procedure: Management of Therapy Complications
Other: Questionnaire Administration
- Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis) [ Time Frame: During the 6 days following chemotherapy ]Number of participants who had complete control defined by no vomiting
- Change in Vomiting, Nausea and Total FLIE Scores [ Time Frame: Baseline to day 6 ]
- Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0 [ Time Frame: Up to day 6 ]Adverse events at least possibly related to treatment
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275664
|United States, Illinois|
|Sudarshan K Sharma MD Limted-Gynecologic Oncology|
|Hinsdale, Illinois, United States, 60521|
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Steven Plaxe||NRG Oncology|