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

This study has been completed.
Sponsor:
Information provided by:
Shantha Biotechnics Limited
ClinicalTrials.gov Identifier:
NCT00776165
First received: October 20, 2008
Last updated: February 1, 2010
Last verified: February 2010
History of Changes
  Purpose

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.

Condition Intervention Phase
Chemotherapy-Induced Neutropenia
 Biological: Recombinant Human GCSF (Shantha Biotechnics Limited)
Biological: Neupogen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fever
U.S. FDA Resources

Further study details as provided by Shantha Biotechnics Limited:

Primary Outcome Measures:
  • 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. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients developing adverse events and/ or changes in laboratory values. [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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
Active Comparator: 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
 Biological: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776165

Locations
India
Indo American Cancer Institute and Research Centre
Hyderabad, Andhra Pradesh, India, 500034
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500034
Vedanta Institute of Medical Sciences
Ahmedabad, Gujrat, India, 380009
Lakeshore Hospital and Research Center
Cochin, Kerala, India, 682404
Regional Cancer Centre
Trivandrum, Kerala, India, 695011
Seth Ramdas Shah Memorial Hospital
Pune, Maharashtra, India, 411016
SMS Medical College and Hospital
Jaipur, Rajasthan, India, 302004
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
Study Director: Raman Rao, MD Shantha Biotechnics Limited, Hyderabad, India
  More Information

No publications provided

Responsible Party: Dr. Raman Rao, Shantha Biotechnics Limited, Hyderabad, India
ClinicalTrials.gov Identifier: NCT00776165     History of Changes
Other Study ID Numbers: SBL/GCSF/N/2007/0100
Study First Received: October 20, 2008
Last Updated: February 1, 2010
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013