Trial Outcomes & Findings for Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer (NCT NCT01275664)
NCT ID: NCT01275664
Last Updated: 2018-05-22
Results Overview
Number of participants who had complete control defined by no vomiting
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
During the 6 days following chemotherapy
Results posted on
2018-05-22
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Granisetron, Dexamethasone, Aprepitant)
n=4 Participants
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
|
|---|---|
|
Age, Customized
40-49 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 6 days following chemotherapyNumber of participants who had complete control defined by no vomiting
Outcome measures
| Measure |
Treatment (Granisetron, Dexamethasone, Aprepitant)
n=4 Participants
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
|
|---|---|
|
Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 6Population: Data was not collected. Funding withdrawn.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 6Population: All eligible and evaluable subjects
Adverse events at least possibly related to treatment
Outcome measures
| Measure |
Treatment (Granisetron, Dexamethasone, Aprepitant)
n=4 Participants
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
|
|---|---|
|
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Fatigue
|
1 Participants
|
|
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Diarrhea
|
1 Participants
|
|
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Constipation
|
1 Participants
|
|
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Hyponatremia
|
1 Participants
|
|
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Alanine Aminotransferase Increased
|
1 Participants
|
|
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
GGT Increased
|
1 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data not collected. Funding withdrawn
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to day 6Population: Data not collected. Funding withdrawn.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Granisetron, Dexamethasone, Aprepitant)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Granisetron, Dexamethasone, Aprepitant)
n=4 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Gastrointestinal disorders
Mucositis Oral
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Gastrointestinal disorders
Esophagitis
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Investigations
Platelet Count Decreased
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Investigations
Ggt Increased
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Investigations
Neutrophil Count Decreased
|
50.0%
2/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Investigations
White Blood Cell Decreased
|
50.0%
2/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Investigations
Alanine Aminotransferase Increased
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Assessed day 6 while on treatment and up to 30 days after day 6.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60