A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: Beijing Chest Hospital; Changhai Hospital; First Hospital of China Medical University; Fudan University; Fujian Cancer Hospital; Hospital affiliated to Academy of Military Medical Sciences; Hunan Cancer Hospital; Peking University Third Hospital; Qilu Hospital; Qilu Hospital of Shandong University; The Second Affiliated Hospital of Dalian Medical University; Tianjin Medical University Cancer; Tianjin People's Hospital; West China Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Zhejiang Cancer Hospital
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• diagnosis of malignant solid tumours (excluding highly aggressive lymphomas such as lymphoblastic lymphoma and Burkitt lymphoma)

• chemotherapy naive

• Karnofsky Performance Status ≥70

• age 18-70 years; normal white blood cell (WBC) count and platelet count

• adequate renal, hepatic and cardiac function

• life expectancy ≥3 months

• normal bone marrow function

Exclusion Criteria:

• history of systematic chemotherapy (including adjuvant therapy)

• large area radiotherapy (>25% of bone marrow volume)

• uncontrolled infection

• bone marrow involvement

• pregnancy, lactation

• history of blood stem cell or organ transplantation

• antibiotic administration within 72 hours of enrolment

• long time exposure to glucocorticoids and immunosuppressive agents