Status:
UNKNOWN
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
Lead Sponsor:
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University Cancer Hospital & Institute
Conditions:
Neutropenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Detailed Description
The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01918241
Start Date
July 1 2013
Last Update
November 10 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Institute and Hospital, CAMS
Beijing, China