Germ Cell TumorsPhase 3NCT00572572
Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors
A Phase 3 study testing Aprepitant in people with Germ Cell Tumors, run by Hoosier Cancer Research Network at 6 sites in United States.
Trial summary
Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Germ Cell Tumors
- What is being tested?
- Aprepitant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2007to Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologic, serologic or clinical evidence of germ cell tumor.
- Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens
- Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.
- Male patients 15 years of age or older at time of registration.
- Patient will provide written informed consent and authorization to release personal health information.
Who cannot join
- No known history of anticipatory nausea or vomiting.
- No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
- No known central nervous system (CNS) metastasis.
- No known hypersensitivity to any component of study regimen.
- No concurrent participation in a clinical trial which involves another investigational agent.
- No use of warfarin while on study.
- No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.
- No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Froedtert/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Medical Consultants, P.C.
Muncie, Indiana, 47303
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Providence Portland Medical Center
Portland, Oregon, 97213
Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen
Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.
Read the detailed description
OUTLINE: This is a multi-center trial.
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant or placebo with their first study cycle of chemotherapy and then cross over to opposite treatment with the second study cycle.
Cisplatin-based regimen for germ cell tumors containing 20mg/m2/day IV days 1 through 5, first day of chemotherapy administration is day 1. Permitted treatment regimens:
Regimen 1 (BEP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5 Bleomycin 30 U/IV on days 1, 8, 15
Regimen 2 (EP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5
Regimen 3 (VIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Etoposide (75 mg/m2/day) IV on days 1 to 5
Regimen 4 (VeIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Vinblastine (0.11 mg/kg/day) IV on days 1 and 2
Regimen 5 (EC) Cisplatin (20mg/m2/day) IV on days 1 to 5 Epirubicin (90 mg/m2/day) IV on day 1
Patients are treated on study for two cycles. At the completion of protocol therapy patients will receive additional chemotherapy at the discretion of the treating investigator.
If a patient requires discontinuation of one medication or more on a regimen, the patient must be discontinued from the study.
Performance Status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin < 3 x upper limit of normal
- Aspartate aminotransferase (AST, SGOT) < 3 x upper limit of normal
- Alanine aminotransferase (ALT, SGPT) < 3 x upper limit of normal
- Alk Phos < 3 x upper limit of normal
Renal:
- Serum Creatinine <2 mg/dL
Pulmonary:
- Not specified
- Conditions
- Germ Cell Tumors
- Being tested
- Aprepitant, Placebo
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.
PlaceboDrug
Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Aprepitant, Then Placebo | Experimental | Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2 Receives: Drug: Aprepitant; Drug: Placebo |
| Arm B: Placebo, Then Aprepitant | Experimental | Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2 Receives: Drug: Aprepitant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response.
Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.
Measured: Participants were evaluated from start of treatment through day 8 of cycle 2.
Secondary outcomes (5)
Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)
Proportion of patients with no emesis regardless of use of rescue medication during cycle days 1-5.
Measured: Participants were evaluated from cycle days 1-5.
Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)
Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.
Measured: Participants were evaluated from cycle days 6-8.
Visual Analouge (VAS) 100mm Scale Score
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. The mean VAS scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.
Measured: Days 1-8
MD Anderson Symptom Inventory Score
The MD Anderson Symptom Inventory (MDASI) is a brief measure of the severity and impact of cancer-related symptoms. Thirteen core items measure the severity of symptoms and six additional items measure the impact of symptoms. All items are rated on a scale from 0 (not present or did not interfere) to 10 (maximal severity or interference). The mean value of the total nineteen items ranges from 0 to 10.
Measured: Days 1-8
Preferred Treatment Cycle
Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Germ Cell TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Lawrence Einhorn, M.D., Study chair, Hoosier Oncology Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572572
- Sponsor's protocol ID
- QL05-37
- Status last verified
- Mar 2016
- First submitted
- 11 Dec 2007
- Last updated
- 6 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Albany C, Brames MJ, Fausel C, Johnson CS, Picus J, Einhorn LH. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012 Nov 10;30(32):3998-4003. doi: 10.1200/JCO.2011.39.5558. Epub 2012 Aug 20.
PubMed 22915652
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00572572
- Acronym / sponsor ID
- QL05-37
- Conditions
- Germ Cell Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Posted 6 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.
Detailed description
OUTLINE: This is a multi-center trial.
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant or placebo with their first study cycle of chemotherapy and then cross over to opposite treatment with the second study cycle.
Cisplatin-based regimen for germ cell tumors containing 20mg/m2/day IV days 1 through 5, first day of chemotherapy administration is day 1. Permitted treatment regimens:
Regimen 1 (BEP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5 Bleomycin 30 U/IV on days 1, 8, 15
Regimen 2 (EP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5
Regimen 3 (VIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Etoposide (75 mg/m2/day) IV on days 1 to 5
Regimen 4 (VeIP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Ifosfamide (1200 mg/m2/day) IV on days 1 to 5 (with mesna uroprophylaxis at 100% ifosfamide dosing) Vinblastine (0.11 mg/kg/day) IV on days 1 and 2
Regimen 5 (EC) Cisplatin (20mg/m2/day) IV on days 1 to 5 Epirubicin (90 mg/m2/day) IV on day 1
Patients are treated on study for two cycles. At the completion of protocol therapy patients will receive additional chemotherapy at the discretion of the treating investigator.
If a patient requires discontinuation of one medication or more on a regimen, the patient must be discontinued from the study.
Performance Status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin < 3 x upper limit of normal
- Aspartate aminotransferase (AST, SGOT) < 3 x upper limit of normal
- Alanine aminotransferase (ALT, SGPT) < 3 x upper limit of normal
- Alk Phos < 3 x upper limit of normal
Renal:
- Serum Creatinine <2 mg/dL
Pulmonary:
- Not specified
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Aprepitant, Then Placebo | Experimental | Drug: Aprepitant, Drug: PlaceboParticipants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2 |
| Arm B: Placebo, Then Aprepitant | Experimental | Drug: Aprepitant, Drug: PlaceboParticipants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2 |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic, serologic or clinical evidence of germ cell tumor.
- Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens
- Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.
- Male patients 15 years of age or older at time of registration.
- Patient will provide written informed consent and authorization to release personal health information.
Key exclusion criteria (8 listed)
- No known history of anticipatory nausea or vomiting.
- No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
- No known central nervous system (CNS) metastasis.
- No known hypersensitivity to any component of study regimen.
- No concurrent participation in a clinical trial which involves another investigational agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantSubjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2. | Drug | Arm A: Aprepitant, Then Placebo, Arm B: Placebo, Then Aprepitant |
| PlaceboSubjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2. | Drug | Arm A: Aprepitant, Then Placebo, Arm B: Placebo, Then Aprepitant |
Primary outcome
Complete Response.
Time frame: Participants were evaluated from start of treatment through day 8 of cycle 2.
Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.
5 secondary outcomes
Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)
Time frame: Participants were evaluated from cycle days 1-5.
Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)
Time frame: Participants were evaluated from cycle days 6-8.
Visual Analouge (VAS) 100mm Scale Score
Time frame: Days 1-8
MD Anderson Symptom Inventory Score
Time frame: Days 1-8
Preferred Treatment Cycle
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22915652Albany C, Brames MJ, Fausel C, Johnson CS, Picus J, Einhorn LH. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012 Nov 10;30(32):3998-4003. doi: 10.1200/JCO.2011.39.5558. Epub 2012 Aug 20.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Einhorn, M.D. study chair
Hoosier Oncology Group, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant in people with Germ Cell Tumors, run by Hoosier Cancer Research Network at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response. (time frame: Participants were evaluated from start of treatment through day 8 of cycle 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00572572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.