Status:
COMPLETED
Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)
Lead Sponsor:
Shantha Biotechnics Limited
Conditions:
Chemotherapy-Induced Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Neup...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00776165
Start Date
October 1 2007
End Date
September 1 2009
Last Update
February 3 2010
Active Locations (7)
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1
Indo American Cancer Institute and Research Centre
Hyderabad, Andhra Pradesh, India, 500034
2
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500034
3
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India, 380009
4
Lakeshore Hospital and Research Center
Kochi, Kerala, India, 682404