Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer
Status:
Terminated
Trial end date:
2006-03-01
Target enrollment:
Participant gender:
Summary
The main objective of this study is to compare the effectiveness of Leukine & Neupogen to
decrease the incidence of grade 3 & 4 neutropenia in the treatment of patients receiving
cisplatin & gemcitabine for urothelial (bladder) cancer.
All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles.
Patients will also receive either Leukine (Arm A) or Neupogen (Arm B).
Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot have
undergone previous chemotherapy. Approximately 50 patients will be enrolled into each
treatment arm.
Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment
with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, & 15 of each
21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen
(5 µg/kg) injected under the skin on Days 2-6, 9-13, & 16-20 of each cycle.
Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The
overall trial, including follow-up, is expected to be 3 years in duration.