Trial Outcomes & Findings for Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant (NCT NCT00293384)

NCT ID: NCT00293384

Last Updated: 2016-03-15

Results Overview

No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

at 0-24 hours

Results posted on

2016-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Overall Study STARTED	40
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Overall Study Non-compliance	2
Overall Study Missed dosage/study drug	1
Overall Study Ineligible	2

Baseline Characteristics

Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=40 Participants Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Region of Enrollment United States	40 participants n=99 Participants

PRIMARY outcome

Timeframe: at 0-24 hours

Population: Evaluable for response

No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=35 Participants Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Proportion of Participants With Controlled Acute Vomiting	20 participants

SECONDARY outcome

Timeframe: at 25-120 hours

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=35 Participants Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Delayed Vomiting Controlled	22 participants

SECONDARY outcome

Timeframe: at 0-120 hours

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=35 Participants Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Toxicity Grade 3, 4, or 5	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at 0-120 hours

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=35 Participants Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Overall Nausea Controlled	31 participants

Adverse Events

Aprepitant, Dexamethasone, Cytoxan & Kytril

Serious events: 10 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=35 participants at risk Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Gastrointestinal disorders Diarrhea	2.9% 1/35 • Number of events 1
General disorders Pain	2.9% 1/35
Gastrointestinal disorders Vomiting	5.7% 2/35 • Number of events 2
Infections and infestations Infection	5.7% 2/35 • Number of events 3
Musculoskeletal and connective tissue disorders Musculokeletal Pain	2.9% 1/35 • Number of events 1
Metabolism and nutrition disorders Hypokalemia	2.9% 1/35 • Number of events 2
Blood and lymphatic system disorders Febrile Neutropenia	17.1% 6/35 • Number of events 6
Metabolism and nutrition disorders Hypophosphatemia	2.9% 1/35 • Number of events 2
Metabolism and nutrition disorders Mucositis	2.9% 1/35 • Number of events 1
Renal and urinary disorders Hydronephrosis	2.9% 1/35 • Number of events 1

Other adverse events

Other adverse events
Measure	Aprepitant, Dexamethasone, Cytoxan & Kytril n=35 participants at risk Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 \& 3: Aprepitant 80 mg once daily in the morning. Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3 Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
General disorders Fever	17.1% 6/35 • Number of events 6
Skin and subcutaneous tissue disorders Rash	8.6% 3/35 • Number of events 3
Gastrointestinal disorders Nausea	68.6% 24/35 • Number of events 47
Gastrointestinal disorders Diarrhea	28.6% 10/35 • Number of events 12
Gastrointestinal disorders Vomiting	40.0% 14/35 • Number of events 16
Infections and infestations Infection	5.7% 2/35 • Number of events 2
Nervous system disorders Headache	20.0% 7/35 • Number of events 8
Respiratory, thoracic and mediastinal disorders Hiccups	20.0% 7/35 • Number of events 7
Cardiac disorders Tachycardia	8.6% 3/35 • Number of events 3
Nervous system disorders Neuropathy	8.6% 3/35 • Number of events 3
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	20.0% 7/35 • Number of events 8
Metabolism and nutrition disorders Hypokalemia	42.9% 15/35 • Number of events 19
General disorders Pain- Cath site	5.7% 2/35 • Number of events 2
General disorders Fatigue	48.6% 17/35 • Number of events 22
Gastrointestinal disorders Constipation	11.4% 4/35 • Number of events 4
Gastrointestinal disorders Belching	5.7% 2/35 • Number of events 2
Nervous system disorders Lightheaded	5.7% 2/35 • Number of events 2
Gastrointestinal disorders Acid Refulx	5.7% 2/35 • Number of events 2
Investigations Weight gain	5.7% 2/35 • Number of events 3
Metabolism and nutrition disorders Hypophosphatemia	14.3% 5/35 • Number of events 5
Psychiatric disorders Insomnia	8.6% 3/35 • Number of events 3
Gastrointestinal disorders Mucositis	5.7% 2/35 • Number of events 2
Nervous system disorders Drowsy	5.7% 2/35 • Number of events 2

Additional Information

Muneer Abidi, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: (313) 576-8713

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place