Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Collaborators: Beijing Cancer Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Changsha Central Hospital; Jiangsu Cancer Institute & Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shandong Cancer Hospital and Institute; Subei People's Hospital of Jiangsu Province; The Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital with Nanjing Medical University; Wuhan TongJi Hospital; Yangzhou No.1 People's Hospital
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Age:18-70 years；

• Comfirmed advanced tumor patients by histopathological with regarding initialtreatment or adjuvant, or neoadjuvant chemotherapy,suitable for chemotherapy with canboplatin combined with taxol or cyclophosphamide combined with pharmorubicin in the opinion of the investigator；

• Performance status（EOCG）≤1；

• Normal human peripheral blood are eligible for the chemotherapy, WBC≥3,500 per cubic millilit, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter；

• Normal ECG examination；

• Without liver metastasis patients: the level of ALT、TBIL、AST were in the 2.5 times of upper normal limit; Liver metastasis patients: the level of ALT、TBIL、AST were in the 5 times of upper normal limit;

• Renal function indices：the level of Cr、BUN were bothe in the 1.25 times of upper normal limit;

• Life expectancy >3 months;

• Signed informed consent.

Exclusion Criteria:

• Be treated with radiotherapy in nearly 4 weeks(not included local radiotherapy for the bone metastasis);

• Be treated with hemopoietic stem cell transplantation or bone marrow transplant；

• Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature > 38.2℃)

• Evidence of metastatic disease in bone marrow,or with other malignant tumors （not included cured basal cell carcinoma and endometrial carcinoma）；

• Subjects with unconscious or symptomatic brain metastases；

• Subjects with serious heart、liver and renal disease;

• Subjects with serious diabetes or poor control in glycemia;

• Pregnant or breast-feeding period females;

• Be treated with antibiotics in 72 hours or currently being treated with antibiotics;

• Treated with PEG-rhG-CSF in past;

• Participated 3 or more than 3 clinical trials in nearly a year(as subjects) or any clinical trials in nearly 3 months;

• Allergic disorders or allergies subjects or known hypersensitivity to filgrastim or any of the products to be administered during dosing;

• Suspected or comfirmed evidences of drug、treatment of drugs or alcohol abused;

• Serious Neurological disorders that would affect the consent or observation;

• Other conditions which in the opinion of the investigator preclude enrollment into the study.