A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy

Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim administration has long been established as the standard of care. A pegylated filgrastim was independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. These characters were similar to those of Neulasta.

The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the efficacy and safety of a single injection of pegylated filgrastim and daily injections of filgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is that pegylated filgrastim is similarly effective and safe with regular filgrastim.

Conditions

• Cancer

Interventions

DRUG

pegylated filgrastim and filgrastim

patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and filgrastim 5 ug/kg/d in cycle 2

DRUG

filgrastim and pegylated filgrastim

patients received filgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2

Sponsors & Collaborators

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Beijing Chest Hospital

  collaborator OTHER

• Hospital affiliated to Academy of Military Medical Sciences

  collaborator UNKNOWN

• Tianjin Medical University Cancer

  collaborator UNKNOWN

• Fudan University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Tianjin People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Yuankai Shi, M.D. · Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, China

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2007-05-31

Completion

2008-12-31