Neoplasms (no Otherwise Specified) Clinical Trial
Official title:
A Phase IV Clinical Trial of Patients With Solid Tumours Receiving Granocyte 34 (Granulocyte Colony Stimulating Factor (G-CSF)) as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Taxotere (Docetaxel) Based Regimen
Primary Objective:
To evaluate the incidence and severity of neutropenia in patients being treated for solid
tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary
prophylaxis for chemotherapy-induced neutropenia.
Secondary Objectives:
Haematological : To evaluate the incidence and severity of febrile neutropenia (with or
without antibiotics) and anaemia in patients being treated for solid tumors treated with a
Taxotere based regimen when Granocyte is being used as a primary prophylaxis.
Non-Haematological : To evaluate the incidence and severity of the following adverse events:
asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours
treated with a Taxotere based regimen; when Granocyte is being used as a primary
prophylaxis.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment