Clinical trial NCT01107756: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms (no Otherwise Specified)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 403
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
timeFrame: 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:
measure: Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Incidence and severity of asthenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Incidence and severity of anorexia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Incidence and severity of myalgia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Incidence and severity of nails changes, including nail disorders assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Incidence and severity of oral mucositis assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
timeFrame: 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
measure: Neutropenia/febrile neutropenia associated days in hospital
timeFrame: 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
measure: Neutropenia/febrile neutropenia associated use of anti-infectives
timeFrame: 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
measure: Incidence of chemotherapy dose reduction, withdrawals or treatment delays due to neutropenia or febrile neutropenia
timeFrame: 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
measure: Infection with (or without) neutropenia
timeFrame: 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
measure: Relationship between the incidence and severity of neutropenia and the different chemotherapy regimens
timeFrame: 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
Other outcomes:
Locations:
city: Alberton
country: South Africa
facility: Investigational Site Number 53
city: Amanzimtoti
country: South Africa
facility: Investigational Site Number 012
city: Benoni
country: South Africa
facility: Investigational Site Number 55
city: Bloemfontein
country: South Africa
facility: Investigational Site Number 11
city: Cape Town
country: South Africa
facility: Investigational Site Number 21
city: Cape Town
country: South Africa
facility: Investigational Site Number 27
city: Cape Town
country: South Africa
facility: Investigational Site Number 26
city: Cape Town
country: South Africa
facility: Investigational Site Number 22
city: Durban
country: South Africa
facility: Investigational Site Number 13
city: Durban
country: South Africa
facility: Investigational Site Number 14
city: East London
country: South Africa
facility: Investigational Site Number 32
city: George
country: South Africa
facility: Investigational Site Number 24
city: Johannesburg
country: South Africa
facility: Investigational Site Number 51
city: Johannesburg
country: South Africa
facility: Investigational Site Number 12387
city: Klerksdorp
country: South Africa
facility: Investigational Site Number 47
city: Nelspruit
country: South Africa
facility: Investigational Site Number 43
city: Polokwane
country: South Africa
facility: Investigational Site Number 44
city: Port Elizabeth
country: South Africa
facility: Investigational Site Number 31
city: Pretoria
country: South Africa
facility: Investigational Site Number 42
city: Pretoria
country: South Africa
facility: Investigational Site Number 41
city: Pretoria
country: South Africa
facility: Investigational Site Number 451
city: Rustenburg
country: South Africa
facility: Investigational Site Number 48
city: Sandton
country: South Africa
facility: Investigational Site Number 54
city: Somerset West
country: South Africa
facility: Investigational Site Number 25
city: Vereeniging
country: South Africa
facility: Investigational Site Number 56
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: