Neutropenia | Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
Neutropenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:pegfilgrastim,30mcg/kgTwo doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.
Drug:pegfilgrastim, 60mcg/kgSingle SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
Drug:pegfilgrastim, 100mcg/kgSingle SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
Drug:filgrastim, 5mcg/kgAt least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
pegfilgrastim,30mcg/kgOn the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg.
pegfilgrastim, 60mcg/kgOn the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg.
pegfilgrastim,100mcg/kgOn the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg.
filgrastim,5mcg/kgOn the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days.
Start Date: July 2013
Phase: Phase 2
Primary Outcome: Duration of ≥grade 3 neutropenia in cycle 2
Secondary Outcome: change of Neutropenia and ANC in cycle 2
Study sponsors, principal investigator, and references
Principal Investigator: Yuankai Shi
Lead Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborator: Cancer Institute and Hospital, Chinese Academy of Medical Sciences