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IRCT2013042212398N4 IRCT 2014-03-17 Actoverco Pharmaceutic Company Determining the effectiveness, safety and tolerability of Actoverco Filgrastim and Actoverco Pegfilgrastim compared to Neupogen in preventing the chemotherapy induced neutopenia in treatment of the breast cancer A Randomized parallel group clinical trial to determine the effectiveness, safety and tolerability of Actoverco Filgrastim and Actoverco Pegfilgrastim compared to Neupogen® for prevention of chemotherapy induced neutropenia in the treatment of the breast cancer 2014-01-21 anticipated 156 Complete https://irct.ir/trial/12464 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 3 breast cancer. Intervention 1: Intervention group: Twenty four hours after each cycle of chemotherapy, injections of filgrastim (0.5 mIU/kg/day until post nadir ANC recovery)or Pegfilgrastim (6 mg, single dose)will be done. Protocol of chemotherapy drugs On the first day of each cycle: On the first day of each cycle associated to AC regimen, patients receive an IV bolus of Doxorubicin (60 mg/m2 IV) in 20 min and then Cyclophosphamide (600mg/m2) in 30 minutes. AC regimen is repeated every 14 days for 4 cycles and then followed by Paclitaxel regimen. Patients receive a three-hour Paclitaxel (175 mg/m2 IV) every 14 days for 4 cycles. There is no indication for G-CSF support in cycles 5 to 8 due to lower toxicity of Paclitaxel. Intervention 2: Control group: Twenty four hours after each cycle of chemotherapy, injections of Neopogen (0.5 mIU/kg/day until post nadir ANC recovery)will be done. Protocol of chemotherapy drugs On the first day of each cycle: On the first day of each cycle associated to AC regimen, patients receive an IV bolus of Doxorubicin (60 mg/m2 IV) in 20 min and then Cyclophosphamide (600mg/m2) in 30 minutes. AC regimen is repeated every 14 days for 4 cycles and then followed by Paclitaxel regimen. Patients receive a three-hour Paclitaxel (175 mg/m2 IV) every 14 days for 4 cycles. There is no indication for G-CSF support in cycles 5 to 8 due to lower toxicity of Paclitaxel.
public Dr. Shirin Pournourmohammadi
No.17, 20metri dashte behesht st.,sa`aadat abad
Tehran Iran (Islamic Republic of) 1998678111 +98 21 2206 8479 shirin.pnm@actoverco.com ACTOVERCO Pharmaceutical Company scientific Dr. S. Mohsen Razavi
No.17, 20 metri dasht behesht st.,sa`aadat abad
Tehran Iran (Islamic Republic of) 1998678111 +98 21 8214 1600 s_m_raz@yahoo.com ACTOVERCO Pharmaceutical Company Iran (Islamic Republic of) Inclusion Criteria: Female patients aged 18 to 70 years old; Signed informed consent obtained prior to initiation the study; Patients diagnosed having high risk stage 2 or stage 3 and or 4 of breast cancer (by histopathological or cytological diagnosis) and need chemotherapy; A priori has been decided to be treated with G-CSF and subjects eligible for G-CSF therapy according to indications and clinical use in the product monograph; Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1; ECOG Performance Status 0 or 1 as determined on Day 1 of Cycle 1 prior to administration of chemotherapy; Patients must have adequate organ function including the following: a. Adequate bone marrow functions, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: Hb≥10 g/dL (transfusion permitted to be included in the trial WBC≥3,5 x 109/L,Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelets ≥100 x 109/L , b. Adequate renal and hepatic function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: i. Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria: ii. a) Alkaline phosphatase within normal reference range and both AST and ALT >2.5 x ULN; or b) Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or c ) Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range; Renal: Serum creatinine ≤ 1.5 mg/dL or ≥ 90 ml/min GFR; Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy (Day 1 of Cycle 1) and use at least one form of contraception as approved by the Investigator for four weeks prior to the study and during the study. For the purposes of this study, child-bearing potential is defined as: “All female patients unless they are post-menopausal for at least one year or are surgically sterile”. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository); Life expectancy more than 3 months; Entering to the study before the second cycle of chemotherapy; Ability to co-operate with the treatment and follow up. Exclusion Criteria: Safety of treatment dependent criteria: Presence of any serious concomitant systemic disorders incompatible with the administration of G-CSF or any systemic disease that can influence the patient's safety (according to doctor’s diagnosis); history of hypersensitivity to natural or recombinant G-CSF, or hypersensitivity to human albumin or any other component of the formulation; History of poorly controlled hypertension (BP > 180/110 mmHg) and/or other clinically significant major disease (according to doctor’s diagnosis); Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days; Pregnant or breast-feeding patients; Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV; Known bleeding disorder Criteria dependent on compliance with study procedures, or the evaluation of the response: Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only); Treatment with certain other agents to treat the malignant disease; Patients requiring autologous or allogeneic stem cell transplantation; Patients receiving simultaneous radiotherapy; Patients who have taken colony stimulation factor within the previous 10 days; Treatment with any investigational product within 30 days prior to study drug administration; Previous participation in this study; Having chemotherapy for any reason in the last 5 years and or receiving> 240 mg/m2 doxorubicin or > 600 mg/m2 Epirubicin at the life time; Already involved in this research project. 18 years 70 years Female C50 breast cancer Treatment - Drugs Treatment - Drugs Intervention group: Twenty four hours after each cycle of chemotherapy, injections of filgrastim (0.5 mIU/kg/day until post nadir ANC recovery)or Pegfilgrastim (6 mg, single dose)will be done. Protocol of chemotherapy drugs On the first day of each cycle: On the first day of each cycle associated to AC regimen, patients receive an IV bolus of Doxorubicin (60 mg/m2 IV) in 20 min and then Cyclophosphamide (600mg/m2) in 30 minutes. AC regimen is repeated every 14 days for 4 cycles and then followed by Paclitaxel regimen. Patients receive a three-hour Paclitaxel (175 mg/m2 IV) every 14 days for 4 cycles. There is no indication for G-CSF support in cycles 5 to 8 due to lower toxicity of Paclitaxel. Control group: Twenty four hours after each cycle of chemotherapy, injections of Neopogen (0.5 mIU/kg/day until post nadir ANC recovery)will be done. Protocol of chemotherapy drugs On the first day of each cycle: On the first day of each cycle associated to AC regimen, patients receive an IV bolus of Doxorubicin (60 mg/m2 IV) in 20 min and then Cyclophosphamide (600mg/m2) in 30 minutes. AC regimen is repeated every 14 days for 4 cycles and then followed by Paclitaxel regimen. Patients receive a three-hour Paclitaxel (175 mg/m2 IV) every 14 days for 4 cycles. There is no indication for G-CSF support in cycles 5 to 8 due to lower toxicity of Paclitaxel. Duration of Severe Neutropenia. Timepoint: The number of days that patients have severe neutropenia (defined as above). Method of measurement: Daily Hematology During severe neutropenia. Severe Neutropenia. Timepoint: before intervention, from day 6 to 14 after chemotherapy in first cycle. Method of measurement: Hematology. Drug intolerance. Timepoint: 14 and 21 days after intervention in each cycle. Method of measurement: Doctor`s diagnosis. Febrile neutropenia. Timepoint: before intervention, day 7 and 14 after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: Physical exam and Para clinic. Serious adverse events. Timepoint: Whenever it happens. Method of measurement: Doctor`s observation and report. Fever. Timepoint: before intervention, from day 6 to 14 after chemotherapy in first cycle, day 14 after chemotherapy in second till forth cycle and 30 days after the last dose of chemotherapy. Method of measurement: Thermometer. Fever duration. Timepoint: Whenever a patient has fever. Method of measurement: Physical exam. Height. Timepoint: before intervention. Method of measurement: Meter. ANC. Timepoint: before intervention, from day 6 to 14 after chemotherapy in first cycle, day 7 and 14 after chemotherapy in second till forth cycle and 30 days after the last dose of chemotherapy. Method of measurement: multiplied the percentage of neutrophils in the WBC count. Ability to continue chemotherapy. Timepoint: 14 days after chemotherapy in each cycle. Method of measurement: Doctor`s Report. Weight. Timepoint: befor intervention, 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: Carriage scales. Bone pain. Timepoint: befor intervention, 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: According to patient's Statement. Non-life-threatening side effects. Timepoint: 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: Doctor`s observation and report. Severity of bone pain. Timepoint: 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: according to VAS criteria. Age. Timepoint: before intervention. Method of measurement: According to birthday. Race. Timepoint: before intervention. Method of measurement: According to patient's Statement. Laboratory abnormalities. Timepoint: Before intervention, from day 6 to 14 after chemotherapy in first cycle, day 7 and 14 after chemotherapy in second till forth cycle and 30 days after the last dose of chemotherapy. Method of measurement: Hematology. Hospitalization. Timepoint: Whenever needed during the study. Method of measurement: Doctor`s diagnosis. Duration of Hospitalization. Timepoint: Duration of Hospitalization at any time patient hospitalized. Method of measurement: Review of patient records. Infection. Timepoint: 14 days after intervention in each cycle. Method of measurement: Physical exam and Paraclinic. Need for intravenous antibiotics. Timepoint: 14 days after chemotherapy in each cycle. Method of measurement: Doctor`s prescription. The injection site Pain. Timepoint: 14 and 21 days after intervention in each cycle and 28 days after the end of the study. Method of measurement: According to patient's Statement. Severity of the injection site pain. Timepoint: 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: according to VAS criteria. Functional status. Timepoint: befor intervention, 14 days after chemotherapy in each cycle and 30 days after the last dose of chemotherapy. Method of measurement: ECOG criteria. Exit the study for any reason. Timepoint: Whenever it happens. Method of measurement: Doctor or patient's Statement. Excluded reason. Timepoint: Whenever it happens. Method of measurement: Doctor or patient's Statement. Dosage of chemotherapy. Timepoint: 14 days after intervention in each cycle. Method of measurement: Doctor`s prescription. Stage of breast cancer. Timepoint: before intervention. Method of measurement: TNM criteria. Drug. Timepoint: before intervention. Method of measurement: BBR Table. Actoverco Pharmaceutic Company Approved 2014-12-02 Iran University of Medical Sciences Next to Milad Hospital, between the intersection of Sheykh Fazl Allah Nuri and Chamran, Hemmat Highway. Tehran Iran (Islamic Republic of)