Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

NCT ID: NCT01918241

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31

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 before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC<1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.

【Primary Outcome Measures】:

• Duration of ≥grade 3 neutropenia in cycle 2

【Secondary Outcome Measures】:

• Incidence of ≥grade 3 neutropenia induce;
• Incidence of febrile neutropenia;
• Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;
• Duration for ANC recovery from nadir to 2.0×10^9/L.

Conditions

Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pegfilgrastim,30mcg/kg

On 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.

Group Type: EXPERIMENTAL

pegfilgrastim,30mcg/kg

Intervention Type: DRUG

Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.

pegfilgrastim, 60mcg/kg

On 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.

Group Type: EXPERIMENTAL

pegfilgrastim, 60mcg/kg

Intervention Type: DRUG

Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.

pegfilgrastim,100mcg/kg

On 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.

Group Type: EXPERIMENTAL

pegfilgrastim, 100mcg/kg

Intervention Type: DRUG

Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.

filgrastim,5mcg/kg

On 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.

Group Type: EXPERIMENTAL

filgrastim, 5mcg/kg

Intervention Type: DRUG

At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.

Interventions

pegfilgrastim,30mcg/kg

Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.

Intervention Type: DRUG

pegfilgrastim, 60mcg/kg

Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.

Intervention Type: DRUG

pegfilgrastim, 100mcg/kg

Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.

Intervention Type: DRUG

filgrastim, 5mcg/kg

At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.

Intervention Type: DRUG

Other Intervention Names

PEG-rhG-CSF,30mcg/kg; PEG-rhG-CSF,60mcg/kg; PEG-rhG-CSF,100mcg/kg; rhG-CSF,5mcg/kg

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Wuhan TongJi Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

Changsha Central Hospital

OTHER

Sponsor Role: collaborator

Yangzhou No.1 People's Hospital

OTHER

Sponsor Role: collaborator

Subei People's Hospital of Jiangsu Province

OTHER

Sponsor Role: collaborator

Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuankai Shi

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute and Hospital, CAMS

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Qin, M.D.

Role: CONTACT

010-8778-8507

Other Identifiers

JY062013B

Identifier Type: -

Identifier Source: org_study_id