Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer

Bladder Cancer Clinical Trial

Official title: A Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin and Gemcitabine for Regionally Advanced or Metastatic Urothelial Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Objectives: To compare the efficacy of Leukine and Neupogen in the treatment of patients receiving cisplatin and gemcitabine for regionally advanced or metastatic urothelial cancer in regard to reduction of grade 3 and 4 neutropenia. Secondary objectives include a comparison of: hematologic and non-hematologic toxicities, anti-tumor effects, dose intensity, and quality of life in each treatment arm.

Methodology: The study will be a multi-institutional, randomized, phase III study in patients with regionally advanced or metastatic urothelial cancer. All patients will receive chemotherapy with cisplatin plus gemcitabine for six 21-day cycles. Patients will receive hematopoietic growth factor support with either Leukine (Arm A), or Neupogen (Arm B). Rates of anti-tumor responses and the incidence of toxicities in each treatment arm will provide a comparison of efficacy and safety for the hematopoietic support regimens.

Patient Population: Patients to be enrolled (n=100) in this study will have received a diagnosis of regionally advanced or metastatic urothelial cancer of the bladder, ureter, or renal pelvis and will have not undergone previous systemic chemotherapy. Approximately 50 patients will be enrolled into each treatment arm.

Main Criteria for Inclusion: Inclusion criteria for this study specify that patients have evaluable, biopsy-proven, surgically unresectable, regionally advanced, or metastatic urothelial cancer of the bladder, ureter, or renal pelvis. Additionally, patients must have an Eastern Cooperative Oncology Group performance status of 0-2 and adequate bone marrow, renal, and hepatic function. Patients who have undergone previous systemic chemotherapy will be excluded from this study.

Test Product, Dose, Mode of Administration: All patients will receive chemotherapeutic treatment with cisplatin (70 mg/kg) intravenously on Day 1 and gemcitabine (1000 mg/m2) intravenously on Days 1, 8, and 15 of each 21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen (5 µg/kg) subcutaneously on Days 2-6, 9-13, and 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.

Criteria for Evaluation: Efficacy will be assessed by, incidence of grade 3 and 4 toxicities, evaluation of complete and partial response, time to progression, overall and disease specific survival, planned vs administered doses, and quality of life. Safety will be assessed by, vital signs, physical examinations, clinical laboratory evaluations, and the reporting of adverse events. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer

• NCT number: NCT00237575
• Study type: Interventional
• Source: University of Kentucky
• Status: Terminated
• Phase: Phase 3
• Start date: November 2005
• Completion date: March 2006