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

NCT ID: NCT01107756

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-07-31

Brief 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.

Conditions

Neoplasms (no Otherwise Specified)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)

Taxotere (Docetaxel) is given as background treatment and should be administered by the treating physician in accordance with the prescribing information outlined in the package insert + Granocyte 34 (lenograstim)

Group Type: EXPERIMENTAL

LENOGRASTIM (GRANOGYTE 34)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert

Interventions

LENOGRASTIM (GRANOGYTE 34)

Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Investigational Site Number 012

eManzimtoti, , South Africa

Investigational Site Number 24

George, , South Africa

Investigational Site Number 51

Johannesburg, , South Africa

Investigational Site Number 12387

Johannesburg, , South Africa

Investigational Site Number 47

Klerksdorp, , South Africa

Investigational Site Number 43

Mbombela, , South Africa

Investigational Site Number 44

Polokwane, , South Africa

Investigational Site Number 31

Port Elizabeth, , South Africa

Investigational Site Number 42

Pretoria, , South Africa

Investigational Site Number 41

Pretoria, , South Africa

Investigational Site Number 451

Pretoria, , South Africa

Investigational Site Number 48

Rustenburg, , South Africa

Investigational Site Number 54

Sandton, , South Africa

Investigational Site Number 25

Somerset West, , South Africa

Investigational Site Number 56

Vereeniging, , South Africa

Countries

South Africa

Other Identifiers

U1111-1116-9574

Identifier Type: OTHER

Identifier Source: secondary_id

DOCET_L_04775

Identifier Type: -

Identifier Source: org_study_id