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.
18 Years
N/A
Both
Chemotherapy-Induced Neutropenia
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
End of study
Safety Issue:
No
Principal Investigator
Raman Rao, MD
Investigator Role:
Study Director
Investigator Affiliation:
Shantha Biotechnics Limited, Hyderabad, India
Authority:
India: Drugs Controller General of India
Study ID:
SBL/GCSF/N/2007/0100
NCT ID:
NCT00776165
Start Date:
October 2007
Completion Date:
September 2009
Related Keywords:
- Chemotherapy-Induced Neutropenia
- Neutropenia
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