A Clinical Trial of Patients With Solid Tumours Receiving Granulocyte Colony Stimulating Factor as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Docetaxel Based Regimen

Sanofi403 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

403

Conditions

Neoplasms (no Otherwise Specified)

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients willing to sign informed consent prior to entry into the study, * Patients who have been prescribed a Taxotere based regimen, * Patients who have not yet started with the first Taxotere treatment, * Patients with a histological diagnosis of one of the following solid tumours: breast cancer, non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer, gastric cancer or head and neck cancer. Exclusion criteria: * Patients who are enrolled in another clinical study, * Pregnant and/or breastfeeding patients, including women of childbearing potential not willing to use medically acceptable methods of contraception, * Patients with severe liver impairment, * Patients with severe renal function impairment, * Patients with a known hypersensitivity to Granocyte 34 or its constituents, * Patients with a history of severe hypersensitivity reactions to Taxotere or Polysorbate 80, * Patients with a baseline neutrophil count of \< 1500cells/mm3, * Patients on other drugs that are contra-indications for the use with Taxotere, * Patients on con-current radiotherapy. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (25)

Investigational Site Number 53

Alberton, South Africa

Investigational Site Number 55

Benoni, South Africa

Investigational Site Number 11

Bloemfontein, South Africa

Investigational Site Number 21

Cape Town, South Africa

Investigational Site Number 27

Cape Town, South Africa

Investigational Site Number 26

Cape Town, South Africa

Investigational Site Number 22

Cape Town, South Africa

Investigational Site Number 13

Durban, South Africa

Investigational Site Number 14

Durban, South Africa

Investigational Site Number 32

East London, South Africa

...and 15 more locations

Outcomes

Primary Outcomes

Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Time frame: For each granocyte 34 treatment, from the the study start (visit 1) to the study end (Follow-up visit at 30 (±9) days post Taxotere treatment or with premature withdrawal

Secondary Outcomes

Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4