Clinical trial NCT00776165: Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-Induced Neutropenia
Lead sponsor: Shantha Biotechnics Limited
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: End of study
Secondary outcomes:
measure: Percentage of patients developing adverse events and/ or changes in laboratory values.
timeFrame: End of study
measure: Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever
timeFrame: End of study
measure: Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia
timeFrame: End of study
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Indo American Cancer Institute and Research Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Vedanta Institute of Medical Sciences
state: Gujrat
city: Cochin
country: India
facility: Lakeshore Hospital and Research Center
state: Kerala
city: Trivandrum
country: India
facility: Regional Cancer Centre
state: Kerala
city: Pune
country: India
facility: Seth Ramdas Shah Memorial Hospital
state: Maharashtra
city: Jaipur
country: India
facility: SMS Medical College and Hospital
state: Rajasthan
Study officials:
affiliation: Shantha Biotechnics Limited, Hyderabad, India
name: Raman Rao, MD
role: STUDY_DIRECTOR
References: