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Completed

NCT Number: NCT00776165

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

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.

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Key information

Conditions

Chemotherapy-induced Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Indo American Cancer Institute and Research Centre, Hyderabad, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

    Time frame: End of study

Secondary outcomes

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

    Time frame: End of study

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

    Time frame: End of study

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

    Time frame: End of study

Sponsors and collaborators

Lead sponsor

Shantha Biotechnics Limited

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2008
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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