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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

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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: 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
Interventions: Procedure: Adjuvant Therapy
Drug: Aprepitant
Drug: Carboplatin
Drug: Cisplatin
Drug: Dexamethasone
Drug: Granisetron Transdermal Patch
Procedure: Management of Therapy Complications
Other: Questionnaire Administration

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was opened to patient entry on June 13, 2011 and was closed to accrual on December 12, 2011. The trial closed early because enrollment into this study was dependent on accruing patients simultaneously with GOG 252 (NCT00951496). When GOG 252 closed, there was no patient population to recruit from for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Adjuvant Therapy: Ancillary studies

Aprepitant: Given IV and PO

Carboplatin: Given IP

Cisplatin: Given IP

Dexamethasone: Given PO

Granisetron Transdermal Patch: Apply one patch to upper arm

Management of Therapy Complications: Ancillary studies

Questionnaire Administration: Ancillary studies


Participant Flow:   Overall Study
    Treatment (Granisetron, Dexamethasone, Aprepitant)
STARTED   4 
COMPLETED   4 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible and treated patients

Reporting Groups
  Description
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.

Adjuvant Therapy: Ancillary studies

Aprepitant: Given IV and PO

Carboplatin: Given IP

Cisplatin: Given IP

Dexamethasone: Given PO

Granisetron Transdermal Patch: Apply one patch to upper arm

Management of Therapy Complications: Ancillary studies

Questionnaire Administration: Ancillary studies


Baseline Measures
   Treatment (Granisetron, Dexamethasone, Aprepitant) 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age, Customized 
[Units: Participants]
Count of Participants
 
40-49 years   0 
50-59 years   1 
60-69 years   2 
70-79 years   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Change in Vomiting, Nausea and Total FLIE Scores   [ Time Frame: Baseline to day 6 ]

3.  Secondary:   Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0   [ Time Frame: Up to day 6 ]

4.  Secondary:   Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores   [ Time Frame: Baseline ]

5.  Secondary:   Percentages of Patients With NIDL Based on FLIE   [ Time Frame: Up to day 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Gedeon for Helen Huang, MS
Organization: NRG Oncology
phone: 716-845-1169
e-mail: lgedeon@gogstats.org



Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01275664     History of Changes
Other Study ID Numbers: GOG-0272
NCI-2011-02660 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000692516
GOG-0272 ( Other Identifier: NRG Oncology )
GOG-0272 ( Other Identifier: DCP )
GOG-0272 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Submitted: January 11, 2011
First Posted: January 12, 2011
Results First Submitted: October 10, 2017
Results First Posted: April 12, 2018
Last Update Posted: May 22, 2018