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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01107756
First received: April 13, 2010
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Neoplasms (no Otherwise Specified)
Drug: LENOGRASTIM (GRANOGYTE 34)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of asthenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of anorexia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of myalgia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of nails changes, including nail disorders assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of oral mucositis assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Neutropenia/febrile neutropenia associated days in hospital [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Neutropenia/febrile neutropenia associated use of anti-infectives [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Incidence of chemotherapy dose reduction, withdrawals or treatment delays due to neutropenia or febrile neutropenia [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Infection with (or without) neutropenia [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Relationship between the incidence and severity of neutropenia and the different chemotherapy regimens [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 403
Study Start Date: March 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107756

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01107756     History of Changes
Other Study ID Numbers: DOCET_L_04775, U1111-1116-9574
Study First Received: April 13, 2010
Last Updated: October 4, 2012
Health Authority: South Africa: National Health Research Ethics Council

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Docetaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014