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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
Enrollment 4
Recruitment Details 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  
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
40-49 years
0
   0.0%
50-59 years
1
  25.0%
60-69 years
2
  50.0%
70-79 years
1
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)
Hide Description Number of participants who had complete control defined by no vomiting
Time Frame During the 6 days following chemotherapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
2.Secondary Outcome
Title Change in Vomiting, Nausea and Total FLIE Scores
Hide Description [Not Specified]
Time Frame Baseline to day 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected. Funding withdrawn.
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Hide Description Adverse events at least possibly related to treatment
Time Frame Up to day 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible and evaluable subjects
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Constipation
1
  25.0%
Fatigue
1
  25.0%
Diarrhea
1
  25.0%
Hyponatremia
1
  25.0%
Alanine Aminotransferase Increased
1
  25.0%
GGT Increased
1
  25.0%
4.Secondary Outcome
Title Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores
Hide Description [Not Specified]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected. Funding withdrawn
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentages of Patients With NIDL Based on FLIE
Hide Description [Not Specified]
Time Frame Up to day 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected. Funding withdrawn.
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Assessed day 6 while on treatment and up to 30 days after day 6.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Granisetron, Dexamethasone, Aprepitant)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Granisetron, Dexamethasone, Aprepitant)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Granisetron, Dexamethasone, Aprepitant)
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Granisetron, Dexamethasone, Aprepitant)
Affected / at Risk (%)
Total   3/4 (75.00%) 
Blood and lymphatic system disorders   
Anemia * 1  2/4 (50.00%) 
Ear and labyrinth disorders   
Tinnitus * 1  1/4 (25.00%) 
Gastrointestinal disorders   
Constipation * 1  3/4 (75.00%) 
Diarrhea * 1  2/4 (50.00%) 
Mucositis Oral * 1  1/4 (25.00%) 
Nausea * 1  2/4 (50.00%) 
Esophagitis * 1  1/4 (25.00%) 
General disorders   
Fatigue * 1  2/4 (50.00%) 
Investigations   
Platelet Count Decreased * 1  1/4 (25.00%) 
Ggt Increased * 1  1/4 (25.00%) 
Neutrophil Count Decreased * 1  2/4 (50.00%) 
White Blood Cell Decreased * 1  2/4 (50.00%) 
Aspartate Aminotransferase Increased * 1  1/4 (25.00%) 
Alanine Aminotransferase Increased * 1  1/4 (25.00%) 
Metabolism and nutrition disorders   
Hyponatremia * 1  1/4 (25.00%) 
Nervous system disorders   
Headache * 1  1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  1/4 (25.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Results Point of Contact
Name/Title: Linda Gedeon for Helen Huang, MS
Organization: NRG Oncology
Phone: 716-845-1169
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