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Trial record 11 of 14 for:    "Testicular Germ Cell Cancer" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT01736917
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Collaborators:
Hoosier Cancer Research Network
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lawrence Einhorn, Hoosier Cancer Research Network

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chemotherapy-Induced Nausea and Vomiting
Interventions Drug: Fosaprepitant
Drug: Dexamethasone
Drug: 5HT3
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8

PRN antiemetics allowed at the discretion of the treating investigator

  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl

Period Title: Overall Study
Started 65
Completed 54
Not Completed 11
Reason Not Completed
Adverse Event             1
Protocol Violation             10
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8

PRN antiemetics allowed at the discretion of the treating investigator

  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl

Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
64 participants were consented and treated per protocol. 1 participant listed in participant flow experienced an adverse event during infusion and was immediately taken off study. His baseline characteristics are not included in this table.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants
33
(15 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
0
   0.0%
Male
64
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Hispanic or Latino
3
   4.7%
Not Hispanic or Latino
61
  95.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
64
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants
64
Eastern Cooperative Oncology Group (ECOG) performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants
ECOG PS 0 59
ECOG PS 1 4
ECOG PS 2 1
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:
Cancer Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants
Cancer Stage I 27
Cancer Stage II 24
Cancer Stage III 11
Cancer Stage IS 1
Cancer Stage Unknown 1
[1]
Measure Description:

Stage 0 Abnormal cells are present but have not spread to nearby tissue. Also called carcinoma in situ, or CIS. CIS is not cancer, but it may become cancer.

Stage I, Stage II, and Stage III Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues.

Stage IV The cancer has spread to distant parts of the body.

Prior Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants
Participants with Prior Chemotherapy 5
Participants without Prior Chemotherapy 59
Chemotherapy Regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants
Bleomycin, etoposide, cisplatin 51
Etoposide, cisplatin 10
Vinblastine, ifosfamide, cisplatin 2
Cisplatin, Epirubicin 1
1.Primary Outcome
Title Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
Hide Description complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
Time Frame Days 1-8 of chemotherapy regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description:

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

  • Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator
  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
acute phase(days 1 through 5) 29.6
delayed phase (days 6 through 8) 46.3
overall 24.1
2.Secondary Outcome
Title Total Number of Emetic Episodes
Hide Description total number of emetic episodes
Time Frame Days 1-8 of chemotherapy regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description:

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

  • Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8

PRN antiemetics allowed at the discretion of the treating investigator

  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: episodes
29
3.Secondary Outcome
Title Use of Rescue Medications.
Hide Description Total number of patients who received rescue medications.
Time Frame Days 1-8 of chemotherapy regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description:

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8

PRN antiemetics allowed at the discretion of the treating investigator

  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
37
4.Secondary Outcome
Title Self-Reported Assessment of Nausea
Hide Description

the patient’s self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.

The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day.

Time Frame Days 1-8 of chemotherapy regimen
Hide Outcome Measure Data
Hide Analysis Population Description
54 patients completed the VAS on all 8 days and were eligible for analysis.
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description:

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8

PRN antiemetics allowed at the discretion of the treating investigator

  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl

Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: millimeters
median VAS score - day 1
0
(0 to 24)
median VAS score - day 2
0
(0 to 76)
median VAS score - day 3
4.5
(0 to 60)
median VAS score - day 4
18.5
(0 to 95)
median VAS score - day 5
23.5
(0 to 92)
median VAS score - day 6
12.5
(0 to 80)
median VAS score - day 7
7
(0 to 90)
median VAS score - day 8
3
(0 to 84)
Time Frame Duration of participation on study, up to 8 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Hide Arm/Group Description

Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.

- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).

Acute emesis prophylaxis:

  • Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
  • Dexamethasone 20mg PO (orally) daily, D1 and 2
  • Fosaprepitant 150mg IV on day 3

Delayed emesis prophylaxis:

  • Fosaprepitant 150mg IV on D5
  • Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8

PRN antiemetics allowed at the discretion of the treating investigator

  • No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods

Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl

All-Cause Mortality
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Affected / at Risk (%) # Events
Total   9/65 (13.85%)    
Blood and lymphatic system disorders   
FEBRILE NEUTROPENIA * 1  2/65 (3.08%)  2
Cardiac disorders   
MYOCARDIAL INFARCTION * 1  1/65 (1.54%)  1
Gastrointestinal disorders   
DIARRHEA * 1  1/65 (1.54%)  1
Infections and infestations   
ENTEROCOLITIS INFECTIOUS * 1  1/65 (1.54%)  1
SEPSIS * 1  1/65 (1.54%)  1
Metabolism and nutrition disorders   
HYPERKALEMIA * 1  1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders   
PAIN IN EXTREMITY * 1  1/65 (1.54%)  1
Vascular disorders   
HYPERTENSION * 1  1/65 (1.54%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAEv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Affected / at Risk (%) # Events
Total   65/65 (100.00%)    
Blood and lymphatic system disorders   
ANEMIA * 1  13/65 (20.00%)  21
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY * 1  1/65 (1.54%)  1
FEBRILE NEUTROPENIA * 1  1/65 (1.54%)  1
Cardiac disorders   
AORTIC VALVE DISEASE * 1  1/65 (1.54%)  1
CHEST PAIN - CARDIAC * 1  1/65 (1.54%)  1
SINUS TACHYCARDIA * 1  1/65 (1.54%)  1
Ear and labyrinth disorders   
TINNITUS * 1  8/65 (12.31%)  9
Gastrointestinal disorders   
ABDOMINAL PAIN * 1  6/65 (9.23%)  7
BLOATING * 1  4/65 (6.15%)  4
CONSTIPATION * 1  17/65 (26.15%)  19
DIARRHEA * 1  8/65 (12.31%)  10
DRY MOUTH * 1  1/65 (1.54%)  1
DYSPEPSIA * 1  24/65 (36.92%)  29
GASTRITIS * 1  1/65 (1.54%)  1
GASTROESOPHAGEAL REFLUX DISEASE * 1  11/65 (16.92%)  11
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY * 1  2/65 (3.08%)  2
MUCOSITIS ORAL * 1  10/65 (15.38%)  11
NAUSEA * 1  53/65 (81.54%)  90
ORAL PAIN * 1  2/65 (3.08%)  2
TOOTHACHE * 1  1/65 (1.54%)  1
VOMITING * 1  9/65 (13.85%)  9
General disorders   
CHILLS * 1  3/65 (4.62%)  4
EDEMA LIMBS * 1  4/65 (6.15%)  5
FATIGUE * 1  53/65 (81.54%)  78
FEVER * 1  7/65 (10.77%)  7
LOCALIZED EDEMA * 1  1/65 (1.54%)  1
MALAISE * 1  1/65 (1.54%)  1
NON-CARDIAC CHEST PAIN * 1  2/65 (3.08%)  2
PAIN * 1  14/65 (21.54%)  14
Immune system disorders   
ALLERGIC REACTION * 1  1/65 (1.54%)  1
Infections and infestations   
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY * 1  3/65 (4.62%)  4
SINUSITIS * 1  1/65 (1.54%)  1
UPPER RESPIRATORY INFECTION * 1  1/65 (1.54%)  2
Investigations   
ALANINE AMINOTRANSFERASE INCREASED * 1  3/65 (4.62%)  4
ALKALINE PHOSPHATASE INCREASED * 1  2/65 (3.08%)  2
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/65 (1.54%)  2
CHOLESTEROL HIGH * 1  3/65 (4.62%)  3
CREATININE INCREASED * 1  2/65 (3.08%)  2
INR INCREASED * 1  1/65 (1.54%)  5
LYMPHOCYTE COUNT DECREASED * 1  5/65 (7.69%)  9
NEUTROPHIL COUNT DECREASED * 1  14/65 (21.54%)  27
PLATELET COUNT DECREASED * 1  8/65 (12.31%)  14
WEIGHT GAIN * 1  8/65 (12.31%)  8
WHITE BLOOD CELL DECREASED * 1  13/65 (20.00%)  26
Metabolism and nutrition disorders   
ANOREXIA * 1  19/65 (29.23%)  26
DEHYDRATION * 1  1/65 (1.54%)  1
HYPERGLYCEMIA * 1  5/65 (7.69%)  10
HYPERKALEMIA * 1  1/65 (1.54%)  1
HYPERTRIGLYCERIDEMIA * 1  2/65 (3.08%)  2
HYPOALBUMINEMIA * 1  3/65 (4.62%)  3
HYPOCALCEMIA * 1  4/65 (6.15%)  9
HYPOGLYCEMIA * 1  1/65 (1.54%)  1
HYPOKALEMIA * 1  1/65 (1.54%)  7
HYPOMAGNESEMIA * 1  2/65 (3.08%)  2
HYPONATREMIA * 1  5/65 (7.69%)  10
HYPOPHOSPHATEMIA * 1  1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  1/65 (1.54%)  1
BACK PAIN * 1  6/65 (9.23%)  6
BONE PAIN * 1  1/65 (1.54%)  1
CHEST WALL PAIN * 1  2/65 (3.08%)  2
NECK PAIN * 1  3/65 (4.62%)  3
PAIN IN EXTREMITY * 1  4/65 (6.15%)  4
Nervous system disorders   
DIZZINESS * 1  5/65 (7.69%)  6
DYSGEUSIA * 1  3/65 (4.62%)  3
HEADACHE * 1  10/65 (15.38%)  15
MEMORY IMPAIRMENT * 1  1/65 (1.54%)  1
PARESTHESIA * 1  1/65 (1.54%)  1
PERIPHERAL SENSORY NEUROPATHY * 1  4/65 (6.15%)  4
PRESYNCOPE * 1  1/65 (1.54%)  1
SINUS PAIN * 1  1/65 (1.54%)  1
SOMNOLENCE * 1  1/65 (1.54%)  1
SYNCOPE * 1  1/65 (1.54%)  1
Psychiatric disorders   
ANXIETY * 1  9/65 (13.85%)  11
DEPRESSION * 1  3/65 (4.62%)  3
INSOMNIA * 1  13/65 (20.00%)  13
Renal and urinary disorders   
HEMATURIA * 1  1/65 (1.54%)  1
URINARY FREQUENCY * 1  2/65 (3.08%)  2
URINARY RETENTION * 1  1/65 (1.54%)  1
Reproductive system and breast disorders   
AZOOSPERMIA * 1  1/65 (1.54%)  1
ERECTILE DYSFUNCTION * 1  1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders   
COUGH * 1  11/65 (16.92%)  11
DYSPNEA * 1  9/65 (13.85%)  9
EPISTAXIS * 1  1/65 (1.54%)  1
HICCUPS * 1  14/65 (21.54%)  15
HOARSENESS * 1  1/65 (1.54%)  1
HYPOXIA * 1  1/65 (1.54%)  1
NASAL CONGESTION * 1  2/65 (3.08%)  2
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY * 1  1/65 (1.54%)  1
SORE THROAT * 1  4/65 (6.15%)  5
Skin and subcutaneous tissue disorders   
ALOPECIA * 1  14/65 (21.54%)  14
HYPERHIDROSIS * 1  1/65 (1.54%)  1
PAIN OF SKIN * 1  2/65 (3.08%)  2
PRURITUS * 1  5/65 (7.69%)  5
RASH ACNEIFORM * 1  6/65 (9.23%)  6
RASH MACULO-PAPULAR * 1  1/65 (1.54%)  1
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY * 1  2/65 (3.08%)  3
Vascular disorders   
FLUSHING * 1  5/65 (7.69%)  5
HOT FLASHES * 1  2/65 (3.08%)  2
HYPERTENSION * 1  2/65 (3.08%)  2
HYPOTENSION * 1  2/65 (3.08%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAEv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Clinical Data Coordinator
Organization: Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
EMail: jsmith@hoosiercancer.org
Other Publications:
Costantine Albany, Nasser H. Hanna, Joel Picus, Ralph J. Hauke, Christopher A. Fausel, Ziyue Liu, Mary J. Brames, Lawrence H. Einhorn. Phase II study of fosaprepitant plus 5HT3 receptor antagonists plus dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy: Hoosier Oncology Group QL12-153. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4594)
Layout table for additonal information
Responsible Party: Lawrence Einhorn, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01736917     History of Changes
Other Study ID Numbers: QL12-153
First Submitted: November 21, 2012
First Posted: November 29, 2012
Results First Submitted: March 1, 2016
Results First Posted: May 25, 2016
Last Update Posted: May 25, 2016