Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

NCT01918241 | Unknown Phase 2

• 1 other identifier: JY062013B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenia

Keywords

Pegylation; G-CSF; Efficacy; Satety

Outcome Measures

Primary Outcomes (1)

• Duration of ≥grade 3 neutropenia in cycle 2

  21 days

Secondary Outcomes (1)

• change of Neutropenia and ANC in cycle 2

  21 days

Study Arms (4)

pegfilgrastim,30mcg/kg

EXPERIMENTAL

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.

Drug: pegfilgrastim,30mcg/kg

pegfilgrastim, 60mcg/kg

EXPERIMENTAL

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.

Drug: pegfilgrastim, 60mcg/kg

pegfilgrastim,100mcg/kg

EXPERIMENTAL

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.

Drug: pegfilgrastim, 100mcg/kg

filgrastim,5mcg/kg

EXPERIMENTAL

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.

Drug: filgrastim, 5mcg/kg

Interventions

pegfilgrastim,30mcg/kg DRUG

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

Also known as: PEG-rhG-CSF,30mcg/kg

pegfilgrastim,30mcg/kg

pegfilgrastim, 60mcg/kg 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.

Also known as: PEG-rhG-CSF,60mcg/kg

pegfilgrastim, 60mcg/kg

pegfilgrastim, 100mcg/kg 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.

Also known as: PEG-rhG-CSF,100mcg/kg

pegfilgrastim,100mcg/kg

filgrastim, 5mcg/kg DRUG

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

Also known as: rhG-CSF,5mcg/kg

filgrastim,5mcg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cancer Institute and Hospital, CAMS

Beijing, China

RECRUITING

MeSH Terms

Conditions

Neutropenia

Interventions

pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yuankai Shi

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Qin, M.D.

CONTACT

010-8778-8507

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 7, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2016
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

CN (1)