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

Phase 4

Completed

• Conditions: Neoplasms (no Otherwise Specified)
• Interventions: Drug: LENOGRASTIM (GRANOGYTE 34)

• Registration Number: NCT01107756
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-04
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)	LENOGRASTIM (GRANOGYTE 34)	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)

Primary Outcome Measures

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

Name	Time	Method
Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Incidence and severity of asthenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Incidence and severity of anorexia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Incidence and severity of myalgia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Incidence and severity of nails changes, including nail disorders assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Incidence and severity of oral mucositis assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4	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
Neutropenia/febrile neutropenia associated days in hospital	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
Neutropenia/febrile neutropenia associated use of anti-infectives	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
Incidence of chemotherapy dose reduction, withdrawals or treatment delays due to neutropenia or febrile neutropenia	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
Infection with (or without) neutropenia	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
Relationship between the incidence and severity of neutropenia and the different chemotherapy regimens	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

Trial Locations

Locations (25)

Investigational Site Number 27; 🇿🇦 Cape Town, South Africa

Investigational Site Number 48; 🇿🇦 Rustenburg, South Africa

Investigational Site Number 25; 🇿🇦 Somerset West, South Africa

Investigational Site Number 55; 🇿🇦 Benoni, South Africa

Investigational Site Number 21; 🇿🇦 Cape Town, South Africa

Investigational Site Number 26; 🇿🇦 Cape Town, South Africa

Investigational Site Number 47; 🇿🇦 Klerksdorp, South Africa

Investigational Site Number 451; 🇿🇦 Pretoria, South Africa

Investigational Site Number 012; 🇿🇦 Amanzimtoti, South Africa

Investigational Site Number 53; 🇿🇦 Alberton, South Africa

Investigational Site Number 41; 🇿🇦 Pretoria, South Africa

Investigational Site Number 44; 🇿🇦 Polokwane, South Africa

Investigational Site Number 13; 🇿🇦 Durban, South Africa

Investigational Site Number 14; 🇿🇦 Durban, South Africa

Investigational Site Number 56; 🇿🇦 Vereeniging, South Africa

Investigational Site Number 51; 🇿🇦 Johannesburg, South Africa

Investigational Site Number 43; 🇿🇦 Nelspruit, South Africa

Investigational Site Number 54; 🇿🇦 Sandton, South Africa

Investigational Site Number 42; 🇿🇦 Pretoria, South Africa

Investigational Site Number 11; 🇿🇦 Bloemfontein, South Africa

Investigational Site Number 22; 🇿🇦 Cape Town, South Africa

Investigational Site Number 32; 🇿🇦 East London, South Africa

Investigational Site Number 31; 🇿🇦 Port Elizabeth, South Africa

Investigational Site Number 12387; 🇿🇦 Johannesburg, South Africa

Investigational Site Number 24; 🇿🇦 George, South Africa