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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


Phase 3
15 Years
N/A
Not Enrolling
Male
Germ Cell Tumors

Thank you

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 CenterSaint Louis, Missouri  63110
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Providence Portland Medical CenterPortland, Oregon  97213-3635
Medical Consultants, P.C.Muncie, Indiana  47303
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Froedtert/Medical College of WisconsinMilwaukee, Wisconsin  53226