Clinical Trial: Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergo

Brief 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. 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 Summary:

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 m
Sponsor: Hoosier Cancer Research Network

Current Primary Outcome: Complete Response. [ Time Frame: Participants were evaluated from start of treatment through day 8 of cycle 2. ]

Original Primary Outcome: 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. [ Time Frame: 2 months ]

Current Secondary Outcome:

• 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 regardless of use of rescue medication during 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. ]
  Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.
• Visual Analouge (VAS) 100mm Scale Score [ Time Frame: Days 1-8 ]
  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.
• MD Anderson Symptom Inventory Score [ Time Frame: Days 1-8 ]
  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.
• Preferred Treatment Cycle [ Time Frame: 2 months ]
  Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.

Original Secondary Outcome:

• To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute and delayed CINV measured by the proportion of patients with no emesis. [ Time Frame: 2 months ]
• 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 no nausea. [ Time Frame: 2 months ]
• 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 presence of symptoms measured by the MD Anderson Symptom Inventory. [ Time Frame: 2 months ]
• To compare aprepitant with placebo in addition to standard antiemetic prophylaxis in preventing acute and delayed CINV measured by the proportion of patients who state a preference for either aprepitant or placebo. [ Time Frame: 2 months ]
• To explore prevalence of polymorphisms of genes that encode for drug metabolizing enzymes, receptors, and drug transporters involved in the activity of anti-emetics used in the prophylaxis of CINV in patients with GCT. [ Time Frame: 2 months ]

Dates:
Date Received: December 11, 2007
Date Started: December 2007
Date Completion:
Last Updated: March 8, 2016
Last Verified: March 2016