STUDY TO EVALUATE THE SAFETY AND EFFICACY OF rhG-CSF THERAPY FOR MYELOSUPPRESSIVE CHEMOTHERAPY INDUCED NEUTROPENIA
- Conditions
- Health Condition 1: null- High risk for Myelosuppressive chemotherapy induced neutropenia.
- Registration Number
- CTRI/2010/091/000023
- Lead Sponsor
- G C CHEMIE PHARMIE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Cancer patients of either sex under the age group of 18-70 yrs, receiving Myelosuppressive chemotherapy
Patient not receiving any rhG-CSF therapy.
Haematological Investigation
- Absolute neutrophil count >=1500 /mm3
-Haemoglobin at least 9.0 g/dL
-Platelet count at least 100,000/mm3
Hepatic
-Bilirubin less than 2.5 times upper limit of normal (ULN)
-SGPT less than 5 times ULN
Renal
-Creatinine normal OR < 1.5 Ã? upper limit of normal
Cardiovascular
-Ejection fraction normal by MUGA or echocardiogram
Be able to provide signed informed consent.
Women of childbearing potential have a negative urine pregnancy test at the Screening Visit. Furthermore, they must be using a medically accepted method of birth control (i.e., oral, parenteral or implanted contraceptive for at least one month prior to study entry; IUD in place for at least one month prior to study entry; or spermicidal plus barrier methods) and agree to continue to use their present method of birth control throughout the study.
Patient receiving rhG-CSF therapy prior to the study.
Known or suspected hypersensitivity to the study drug or its components, such as avian products, including influenza vaccine, or to E. coli-derived proteins.
Pregnant or lactating woman.
History or clinical evidence of a serious medical illness, including renal, hepatic, respiratory, cardiovascular, endocrine, neurologic, psychiatric, or hematologic disease, which in the opinion of the investigator will interfere with study participation.
Total lifetime exposure to doxorubicin >240 mg/m2 or epirubicin >600 mg/m2
Prior bone marrow or stem cell transplantation
Metastatic brain or meningeal tumors.
Ascites or pleural effusions.
Any active infection requiring systemic antimicrobial therapy
Currently receiving radiation therapy for treatment of a malignant condition, or have completed radiation therapy within 14 days before study entry. Radiation therapy for oncologic emergency is allowed.
Participated in another therapeutic clinical study (i.e., not an epidemiological study or to simultaneously participate in another therapeutic clinical study. genomic screening study) during the past 30 days, or are likely
Have known drug or alcohol dependence
History of hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past twelve (12) months
History or evidence of myocardial infarction, unstable angina pectoris, or stable angina within the past six (6) months.
History or evidence of gastrointestinal disease or surgery, which might interfere with drug absorption.
Have any clinically significant abnormalities on pre-study laboratory screening evaluations.
Are mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures.
Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol (e.g., poorly compliant subject).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy end point is the duration of grade-4 neutropenia (define as ANC < 500/mm3) in chemotherapy cycle-1.Timepoint: 14 Days
- Secondary Outcome Measures
Name Time Method Duration of grade-4 neutropenia in chemotherapy cycle-2, ? Depth of ANC nadir in each of the cycles-1 & 2, ? Time of ANC recovery in chemotherapy cycle-1 & 2 ? Rates of febrile neutropenia ? Incidence of i.v administration of antibioticsTimepoint: 14 days