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

NCT00776165 | Completed Phase 3

• 1 other identifier: SBL/GCSF/N/2007/0100
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Chemotherapy-Induced Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of patients developing adverse events and/ or changes in laboratory values.

  End of study

• Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever

  End of study

• Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia

  End of study

Study Arms (2)

1

EXPERIMENTAL

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

Biological: Recombinant Human GCSF (Shantha Biotechnics Limited)

2

ACTIVE COMPARATOR

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

Biological: Neupogen

Interventions

Recombinant Human GCSF (Shantha Biotechnics Limited) BIOLOGICAL

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

1

Neupogen BIOLOGICAL

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shantha Biotechnics Limited: lead

Study Sites (7)

Indo American Cancer Institute and Research Centre

Hyderabad, Andhra Pradesh, 500034, India

Location

Nizam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, 500034, India

Location

Vedanta Institute of Medical Sciences

Ahmedabad, Gujarat, 380009, India

Location

Lakeshore Hospital and Research Center

Kochi, Kerala, 682404, India

Location

Regional Cancer Centre

Trivandrum, Kerala, 695011, India

Location

Seth Ramdas Shah Memorial Hospital

Pune, Maharashtra, 411016, India

Location

SMS Medical College and Hospital

Jaipur, Rajasthan, 302004, India

Location

MeSH Terms

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Raman Rao, MD

  Shantha Biotechnics Limited, Hyderabad, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

IN (7)