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

Chemotherapy-Induced Neutropenia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776165
• Other study ID #: SBL/GCSF/N/2007/0100
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2008
• Last updated: February 1, 2010
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2010
• Source: Shantha Biotechnics Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-Induced Neutropenia
• Neutropenia

Intervention

Biological:
• Recombinant Human GCSF (Shantha Biotechnics Limited)
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
• Neupogen
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

Locations

Country	Name	City	State
India	Vedanta Institute of Medical Sciences	Ahmedabad	Gujrat
India	Lakeshore Hospital and Research Center	Cochin	Kerala
India	Indo American Cancer Institute and Research Centre	Hyderabad	Andhra Pradesh
India	Nizam's Institute of Medical Sciences	Hyderabad	Andhra Pradesh
India	SMS Medical College and Hospital	Jaipur	Rajasthan
India	Seth Ramdas Shah Memorial Hospital	Pune	Maharashtra
India	Regional Cancer Centre	Trivandrum	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		End of study	No
Secondary	Percentage of patients developing adverse events and/ or changes in laboratory values.		End of study	Yes
Secondary	Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever		End of study	No
Secondary	Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia		End of study	No