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

Last updated: February 1, 2010
Sponsor: Shantha Biotechnics Limited
Overall Status: Completed

Phase

3

Condition

Neutropenia

Effects Of Chemotherapy

Treatment

N/A

Clinical Study ID

NCT00776165
SBL/GCSF/N/2007/0100
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of either sex aged 18 yrs or more

  • Patients diagnosed having any malignancy (except myeloid malignancies andmyelodysplastic syndromes) receiving standard combination chemotherapy.

  • Patients experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previouschemotherapy cycle and have one more cycle of chemotherapy on the same drugs.

  • Patients should have performance status of 0-2 ECOG (European Cooperative Oncologygroup).

Exclusion

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 exceptmalignancy

  • 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

Total Participants: 126
Study Start date:
October 01, 2007
Estimated Completion Date:
September 30, 2009

Connect with a study center

  • Indo American Cancer Institute and Research Centre

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Nizam's Institute of Medical Sciences

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Vedanta Institute of Medical Sciences

    Ahmedabad, Gujrat 380009
    India

    Site Not Available

  • Lakeshore Hospital and Research Center

    Cochin, Kerala 682404
    India

    Site Not Available

  • Regional Cancer Centre

    Trivandrum, Kerala 695011
    India

    Site Not Available

  • Seth Ramdas Shah Memorial Hospital

    Pune, Maharashtra 411016
    India

    Site Not Available

  • SMS Medical College and Hospital

    Jaipur, Rajasthan 302004
    India

    Site Not Available

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