Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)

Shantha Biotechnics

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-Induced Neutropenia

Treatments: Biological: Neupogen; Biological: Recombinant Human GCSF (Shantha Biotechnics Limited)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776165

SBL/GCSF/N/2007/0100

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Biological: Recombinant Human GCSF (Shantha Biotechnics Limited)

2

Active Comparator group

Description:

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

Treatment:

Biological: Neupogen