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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

April 13, 2010
October 4, 2012
March 2010
July 2012   (final data collection date for primary outcome measure)
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 ]
Measure of the 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 ]
Complete list of historical versions of study NCT01107756 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate the 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 ]
  • To evaluate the 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 ]
  • To evaluate the 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 ]
  • To evaluate the 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 ]
  • To evaluate the 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 ]
  • To evaluate the 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 ]
  • To evaluate the 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 ]
  • To record 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 ]
  • To record 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 ]
  • To evaluate the Euroquol quality of life questionnaire (EQ-5D) [ Time Frame: prior to each taxotere treatment ] [ 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 ]
  • to record 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 ]
  • To record the 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 ]
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms (no Otherwise Specified)
Drug: LENOGRASTIM (GRANOGYTE 34)
Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert
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)
Intervention: Drug: LENOGRASTIM (GRANOGYTE 34)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
July 2012
July 2012   (final data collection date for primary outcome measure)

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.

Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01107756
DOCET_L_04775, U1111-1116-9574
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP