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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Docetaxel; Lenograstim

Criteria

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.