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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)

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ClinicalTrials.gov Identifier: NCT01107756
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Neoplasms (no Otherwise Specified) Drug: LENOGRASTIM (GRANOGYTE 34) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107756


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01107756    
Other Study ID Numbers: DOCET_L_04775
U1111-1116-9574 ( Other Identifier: UTN )
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Docetaxel
Sargramostim
Lenograstim
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic