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)

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms (no Otherwise Specified)
• Intervention / Treatment: Drug: LENOGRASTIM (GRANOGYTE 34)

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Africa
  • Alberton, South Africa
    • Investigational Site Number 53
  • Amanzimtoti, South Africa, 4126
    • Investigational Site Number 012
  • Benoni, South Africa
    • Investigational Site Number 55
  • Bloemfontein, South Africa, 9301
    • Investigational Site Number 11
  • Cape Town, South Africa, 7460
    • Investigational Site Number 21
  • Cape Town, South Africa, 7500
    • Investigational Site Number 27
  • Cape Town, South Africa, 7800
    • Investigational Site Number 26
  • Cape Town, South Africa, 7925
    • Investigational Site Number 22
  • Durban, South Africa, 4001
    • Investigational Site Number 13
  • Durban, South Africa, 4091
    • Investigational Site Number 14
  • East London, South Africa
    • Investigational Site Number 32
  • George, South Africa, 6530
    • Investigational Site Number 24
  • Johannesburg, South Africa, 1709
    • Investigational Site Number 51
  • Johannesburg, South Africa, 2000
    • Investigational Site Number 12387
  • Klerksdorp, South Africa, 2572
    • Investigational Site Number 47
  • Nelspruit, South Africa, 1200
    • Investigational Site Number 43
  • Polokwane, South Africa, 0699
    • Investigational Site Number 44
  • Port Elizabeth, South Africa, 6045
    • Investigational Site Number 31
  • Pretoria, South Africa, 0084
    • Investigational Site Number 42
  • Pretoria, South Africa, 0102
    • Investigational Site Number 41
  • Pretoria, South Africa
    • Investigational Site Number 451
  • Rustenburg, South Africa
    • Investigational Site Number 48
  • Sandton, South Africa, 2193
    • Investigational Site Number 54
  • Somerset West, South Africa
    • Investigational Site Number 25
  • Vereeniging, South Africa
    • Investigational Site Number 56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: LENOGRASTIM (GRANOGYTE 34); Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: DOCET_L_04775; U1111-1116-9574 (Other Identifier: UTN)