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:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01107756
First received: April 13, 2010
Last updated: October 4, 2012
Last verified: October 2012
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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:
Genetics Home Reference related topics:
cyclic neutropenia
Drug Information available for:
Docetaxel
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
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
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 27 | |
| Cape Town, South Africa, 7500 | |
| Investigational Site Number 26 | |
| Cape Town, South Africa, 7800 | |
| Investigational Site Number 22 | |
| Cape Town, South Africa, 7925 | |
| Investigational Site Number 21 | |
| Cape Town, South Africa, 7460 | |
| 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:
|
Neoplasms Neutropenia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Lenograstim |
Docetaxel Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013