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 (Grano-Tax)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Neoplasms (no Otherwise Specified)

Treatments: Drug: LENOGRASTIM (GRANOGYTE 34)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107756

U1111-1116-9574 (Other Identifier)

DOCET_L_04775

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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403 participants in 1 patient group

TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)

Experimental group

Description:

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)

Treatment:

Drug: LENOGRASTIM (GRANOGYTE 34)