Health Condition 1: null- NONMYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY
Conditions
Interventions
Intervention1: Peg G-CSF: NA
Control Intervention1: Recombinant human G-CSF: Inj. Neupogen
Sponsors
Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion: The subjects included in the study should satisfy the inclusion criteria enlisted below 1. Adult subject of either sex between age group of 18 to 65 years with histologically confirmed non myeloid malignant tumors undergoing a variety of myelosuppressive chemotherapy regimens 2. Cancer subject with a good performance status (ECOG grade 0-2) 3. Subjects with >= 20% risk of developing chemotherapy induced febrile neutropenia. Subjects receiving chemotherapy regimens with intermediate to high risk for febrile neutropenia are eligible. 4. No serious abnormality of hepatic or renal function at screening. 5. Subject willing to sign the â??Informed Consent Formâ?? Exclusion: The following categories of subjects will be excluded from the study. 1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the Investigator with or without specific investigations. 2. Subject with body weight 3. Current therapy with other investigational drugs or lithium. 4. History or clinical evidence of congestive heart failure. 5. Prior treatment with interferons, interleukins or colony stimulating factors (including G-CSF, GM- CSF, M-CSF and erythropoietin). 6. Subject who has been receiving radiation therapy within 4 weeks of randomization into the study. 7. Prior bone marrow or stem cell transplantation 8. Pregnant women, nursing women and women not practicing effective contraception. 9. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.
Exclusion criteria
Exclusion criteria: 1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the Investigator with or without specific investigations. 2. Subject with body weight < 45 kg 3. Current therapy with other investigational drugs or lithium. 4. History or clinical evidence of congestive heart failure (NYHA class III-IV). 5. Prior treatment with interferons, interleukins, or, colony stimulating factors (including G-CSF, GM- CSF, M-CSF and erythropoietin). 6. Subject who has been receiving radiation therapy within 4 weeks of randomization into the study. 7. Prior bone marrow or stem cell transplantation 8. Pregnant women, nursing women and women not practicing effective contraception. 9. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end point will be the duration in days of the grade IV neutropenia (defined as ANC â?¤ 500 /mm3) in the present chemotherapy cycle.Timepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy will be determined in terms of the following secondary end points: 1. Incidence of febrile neutropenia 2. Incidence of intravenous antibiotic administration 3. Incidence of hospitalizationTimepoint: 10 days | — |
Countries
India
Contacts
Public ContactDr Ashima Bhatia
Outcome results
None listed