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
15 Years
N/A
Male
Germ Cell Tumors
Trial Information
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
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 versus placebo with their first study cycle of
chemotherapy and then cross over to opposite arm with the second study cycle.
Arm A, Study Cycle 1:
Aprepitant 125mg PO day 3 then 80mg on days 4 through 7
Arm A, Study Cycle 2:
Matched placebo PO daily on days 3 through 7
Arm B, Study Cycle 1:
Matched placebo PO daily on days 3 through 7
Arm B, Study Cycle 2:
Aprepitant 125mg PO day 3 then 80mg on days 4 through 7
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- No known history of anticipatory nausea or vomiting.
- No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
- No known 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Outcome Measure:
To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute (days 1 through 5) and delayed (days 6 through 8) CINV measured by the proportion of patients with a Complete Response.
Outcome Time Frame:
2 months
Safety Issue:
No
Principal Investigator
Lawrence Einhorn, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
QL05-37
NCT ID:
NCT00572572
Start Date:
December 2007
Completion Date:
February 2011
Related Keywords:
- Germ Cell Tumors
- Neoplasms, Germ Cell and Embryonal
Name | Location |
|---|---|
| Siteman Cancer Center | Saint Louis, Missouri 63110 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| Medical Consultants, P.C. | Muncie, Indiana 47303 |
| Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
| Froedtert/Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
