Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)
February 1, 2010 updated by: Shantha Biotechnics Limited
A Phase 3 Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.
Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs would be recruited into the study.
Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic chemotherapy in both groups.
Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)
- Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF)
- Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two treatment groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
126
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500034
- Indo American Cancer Institute and Research Centre
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Hyderabad, Andhra Pradesh, India, 500034
- Nizam's Institute of Medical Sciences
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Gujrat
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Ahmedabad, Gujrat, India, 380009
- Vedanta Institute Of Medical Sciences
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Kerala
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Cochin, Kerala, India, 682404
- Lakeshore Hospital and Research Center
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Trivandrum, Kerala, India, 695011
- Regional Cancer Centre
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Maharashtra
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Pune, Maharashtra, India, 411016
- Seth Ramdas Shah Memorial Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- SMS Medical College and Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients of either sex aged 18 yrs or more
- Patients diagnosed having any malignancy (except myeloid malignancies and myelodysplastic syndromes) receiving standard combination chemotherapy.
- Patients experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs.
- Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group).
Exclusion Criteria:
- Patients unwilling to give informed consent or unable to follow study procedures
- Patients requiring autologous or allogenic stem cell transplantation.
- Patients having active infection
- Patients who have taken antibiotics or colony stimulation factor within the previous 10 days
- Patients who have clinically significant uncontrolled medical illness except malignancy
- Patients having renal impairment (serum creatinine > 1.5 times the upper normal limit) and abnormal liver function (bilirubin > 5 times the upper limit of normal)
- Pregnant or lactating women
- Patients who have involvement of bone marrow
- Patients receiving simultaneous radiotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha) Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
|
Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
|
|
Active Comparator: 2
Neupogen (rhG-CSF) Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
|
Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 10e9/L on the same day of the fever or the day after.
Time Frame: End of study
|
End of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of patients developing adverse events and/ or changes in laboratory values.
Time Frame: End of study
|
End of study
|
|
Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever
Time Frame: End of study
|
End of study
|
|
Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia
Time Frame: End of study
|
End of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Raman Rao, MD, Shantha Biotechnics Limited, Hyderabad, India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
October 20, 2008
First Submitted That Met QC Criteria
October 20, 2008
First Posted (Estimate)
October 21, 2008
Study Record Updates
Last Update Posted (Estimate)
February 3, 2010
Last Update Submitted That Met QC Criteria
February 1, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBL/GCSF/N/2007/0100
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