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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chemotherapy-Induced Nausea and Vomiting | Drug: Fosaprepitant Drug: Dexamethasone Drug: 5HT3 | Phase 2 |
OUTLINE: This is a multi-center study.
Treatment Regimen:
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). This will usually be combined with bleomycin (BEP), etoposide (EP), ifosfamide (VIP), vinblastine (VeIP), paclitaxel (TIP) or epirubicin. All of these regimens get the identical cisplatin, which is the only highly emetic drug in any of the chemo regimens.
Acute emesis prophylaxis (administered per institutional standards prior to chemotherapy):
- Any 5HT3 receptor antagonist may be used days 1 through 5 or days 1, 3 and 5 if palonosetron is used per institutional standards.
- Dexamethasone 20mg PO (orally) daily, days 1 and 2
- Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
- Fosaprepitant 150mg IV on day 5
- Dexamethasone 4mg PO BID (twice a day) on days 6, 7 and 8
PRN (as needed) 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
ECOG Performance Status of 0-2
Life Expectancy: Not specified
Hematopoietic:
- White blood cell count (WBC) > 3.0 K/mm3
- Absolute neutrophil count ≥ 1.5 K/mm3
- Hemoglobin (Hgb) > 10 g/dL
- Platelets > 100 K/mm3
Hepatic:
- Bilirubin < 1.5 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN
Renal:
- Creatinine ≤ 2 mg/dl
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-based Chemotherapy: Hoosier Oncology Group Study QL12-153 |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
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.
Acute emesis prophylaxis:
Delayed emesis prophylaxis:
PRN antiemetics allowed at the discretion of the treating investigator
|
Drug: Fosaprepitant
Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis Drug: Dexamethasone Dexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8 Drug: 5HT3 Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used. |
- Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting [ Time Frame: Days 1-8 of chemotherapy regimen ]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
- Total Number of Emetic Episodes [ Time Frame: Days 1-8 of chemotherapy regimen ]total number of emetic episodes
- Use of Rescue Medications. [ Time Frame: Days 1-8 of chemotherapy regimen ]Total number of patients who received rescue medications.
- Self-Reported Assessment of Nausea [ Time Frame: Days 1-8 of chemotherapy regimen ]
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.

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve.
- Written informed consent and HIPAA authorization for release of personal health information.
- Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this criteria is met.
Exclusion Criteria:
- No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year.
- No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No concurrent participation in a clinical trial which involves another investigational agent.
- No use of agents expected to induce the metabolism of fosaprepitant which include: rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates.
- No concurrent use of agents which may inhibit metabolism of fosaprepitant which include: cisapride, macrolide antibiotics (erythromycin, clarithromycin, azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole, fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil and diltiazem, and ritonavir.
- No concurrent use of warfarin while on study.
- No known history of anticipatory nausea or vomiting.
- No clinically significant infections as judged by the treating investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736917
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Missouri | |
Siteman Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Nebraska Cancer Specialists | |
Omaha, Nebraska, United States, 68114 | |
United States, South Carolina | |
MUSC Hollings Cancer Center | |
Charleston, South Carolina, United States, 29425 |
Study Chair: | Lawrence Einhorn, M.D. | Hoosier Cancer Research Network |
Publications of Results:
Other Publications:
Responsible Party: | Lawrence Einhorn, Sponsor-Investigator, Hoosier Cancer Research Network |
ClinicalTrials.gov Identifier: | NCT01736917 |
Other Study ID Numbers: |
QL12-153 |
First Posted: | November 29, 2012 Key Record Dates |
Results First Posted: | May 25, 2016 |
Last Update Posted: | May 25, 2016 |
Last Verified: | April 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fosaprepitant 5HT3 Receptor Antagonists Dexamethasone |
Germ Cell Tumors Testis Cancer Rescue Medications |
Neoplasms, Germ Cell and Embryonal Vomiting Signs and Symptoms, Digestive Neoplasms by Histologic Type Neoplasms Dexamethasone Fosaprepitant Aprepitant Anti-Inflammatory Agents Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Neurokinin-1 Receptor Antagonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |