GCPGC in Chemotherapy-induced Neutropenia
- Conditions
- Chemotherapy Induced Neutropenia
- Interventions
- Biological: GCPGC 6mgBiological: GCPGC 3.6mgBiological: Neulasta (pegfilgrastim) 6mg
- Registration Number
- NCT01328938
- Lead Sponsor
- Green Cross Corporation
- Brief Summary
This study is adaptive design and it consists of stage I and stage II.
Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.
Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.
- Detailed Description
GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol (PEG) which has long half life compared to filgrastim, resulting in dosing advantage.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
- women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia
- body weight of 45kg and more
- ECOG performance status 2 and less
- ANC ≥1,500mm3 and Platelet ≥100,000/mm3
- life expectancy of 3 months and more
- given written informed consent
- had previous exposure to pegfilgrastim or filgrastim
- had received systemic antibiotics within 72hrs of chemotherapy
- prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage I - Arm II: GCPGC II (6mg) GCPGC 6mg GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1) Stage I - Arm I: GCPGC I (3.6mg) GCPGC 3.6mg GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1) Stage II - Arm I: GCPGC GCPGC 6mg GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1). The recommended dose in Stage II was determinated as GCPGC 6mg in Stage I. Stage II - Arm II: Neulasta Neulasta (pegfilgrastim) 6mg Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
- Primary Outcome Measures
Name Time Method Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 in cycle 1 Stage I: The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by check ANC in cycle I.
Stage II : The difference in mean duration of grade 4 neutropenia between GCPGC which dose was determined at Stage I and Neulasta is measured by check ANC in cycle 1.
- Secondary Outcome Measures
Name Time Method ANC values at Day 7 in all cycles (only for Stage II) Day 7 in alll cycles Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II) in clycle 2-6 Number of intravenous antimicrobial treatments due to febrile neutropenia in all cycles Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II) all cycles Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1 in cycle 1 Depth of ANC nadir in cycle 1 in cycle 1 Rates of Febrile neutropenia in all cycles in all cycles Stage I: only in cycle 1; Stage II: in all cycles
Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II) in cycle 1
Trial Locations
- Locations (15)
Inha University Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, KyungKi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan medical Center
🇰🇷Daegu, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chungju, Chungchungbuk, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Sungnam, Kyungki, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul Asan Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Ilsan, KyungKi, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of