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Trial record 6 of 14 for:    "Testicular Germ Cell Cancer" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

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

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ClinicalTrials.gov Identifier: NCT00293384
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : October 3, 2014
Last Update Posted : March 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Muneer Abidi, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Nausea and Vomiting
Neuroblastoma
Ovarian Cancer
Testicular Germ Cell Tumor
Interventions Drug: Aprepitant
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Granisetron hydrochloride
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 40
Completed 35
Not Completed 5
Reason Not Completed
Non-compliance             2
Missed dosage/study drug             1
Ineligible             2
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description

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 Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Patients who received all doses of the study drug were considered evaluable patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
17
  42.5%
Male
23
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Proportion of Participants With Controlled Acute Vomiting
Hide Description No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
Time Frame at 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description:

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 Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aprepitant, Dexamethasone, Cytoxan & Kytril
Comments Optimal Simon design for phase II study. p0=45% p1=65%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments 85% statistical power
Method Simon optimal design
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value .57
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Delayed Vomiting Controlled
Hide Description [Not Specified]
Time Frame at 25-120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description:

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 Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aprepitant, Dexamethasone, Cytoxan & Kytril
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 0.63
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Toxicity Grade 3, 4, or 5
Hide Description [Not Specified]
Time Frame at 0-120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description:

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 Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aprepitant, Dexamethasone, Cytoxan & Kytril
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 0.06
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Overall Nausea Controlled
Hide Description [Not Specified]
Time Frame at 0-120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description:

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 Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
31
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aprepitant, Dexamethasone, Cytoxan & Kytril
Hide Arm/Group Description

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.

All-Cause Mortality
Aprepitant, Dexamethasone, Cytoxan & Kytril
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aprepitant, Dexamethasone, Cytoxan & Kytril
Affected / at Risk (%) # Events
Total   10/35 (28.57%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  2  6/35 (17.14%)  6
Gastrointestinal disorders   
Diarrhea  1  1/35 (2.86%)  1
Vomiting  2  2/35 (5.71%)  2
General disorders   
Pain * 2  1/35 (2.86%) 
Infections and infestations   
Infection  2  2/35 (5.71%)  3
Metabolism and nutrition disorders   
Hypokalemia  2  1/35 (2.86%)  2
Hypophosphatemia  2  1/35 (2.86%)  2
Mucositis  2  1/35 (2.86%)  1
Musculoskeletal and connective tissue disorders   
Musculokeletal Pain  2  1/35 (2.86%)  1
Renal and urinary disorders   
Hydronephrosis  2  1/35 (2.86%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.03
2
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aprepitant, Dexamethasone, Cytoxan & Kytril
Affected / at Risk (%) # Events
Total   33/35 (94.29%)    
Cardiac disorders   
Tachycardia  2  3/35 (8.57%)  3
Gastrointestinal disorders   
Nausea  2  24/35 (68.57%)  47
Diarrhea  2  10/35 (28.57%)  12
Vomiting  2  14/35 (40.00%)  16
Constipation  2  4/35 (11.43%)  4
Belching  2  2/35 (5.71%)  2
Acid Refulx  2  2/35 (5.71%)  2
Mucositis  2  2/35 (5.71%)  2
General disorders   
Fever  1  6/35 (17.14%)  6
Pain- Cath site  2  2/35 (5.71%)  2
Fatigue  2  17/35 (48.57%)  22
Infections and infestations   
Infection  2  2/35 (5.71%)  2
Investigations   
Weight gain  2  2/35 (5.71%)  3
Metabolism and nutrition disorders   
Hypokalemia  2  15/35 (42.86%)  19
Hypophosphatemia  2  5/35 (14.29%)  5
Musculoskeletal and connective tissue disorders   
Musculoskeletal Pain  2  7/35 (20.00%)  8
Nervous system disorders   
Headache  2  7/35 (20.00%)  8
Neuropathy  2  3/35 (8.57%)  3
Lightheaded  2  2/35 (5.71%)  2
Drowsy  2  2/35 (5.71%)  2
Psychiatric disorders   
Insomnia  2  3/35 (8.57%)  3
Respiratory, thoracic and mediastinal disorders   
Hiccups  2  7/35 (20.00%)  7
Skin and subcutaneous tissue disorders   
Rash  2  3/35 (8.57%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE V 3.0
2
Term from vocabulary, CTCAE (3.0)
There were no other significant limitations except for the details provided.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Muneer Abidi, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8713
EMail: abidim@karmanos.org
Layout table for additonal information
Responsible Party: Muneer Abidi, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00293384     History of Changes
Other Study ID Numbers: CDR0000456201
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-D-2797 ( Other Identifier: Karmanos Cancer Institute )
WSU-0504001728 ( Other Identifier: Wayne State University - Human Investigation Committee )
First Submitted: February 16, 2006
First Posted: February 17, 2006
Results First Submitted: May 12, 2014
Results First Posted: October 3, 2014
Last Update Posted: March 15, 2016