Neoplasms (no Otherwise Specified) Clinical Trial
— Grano-TaxOfficial 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
| Verified date | October 2012 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Africa: National Health Research Ethics Council |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 403 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 75 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Investigational Site Number 53 | Alberton | |
| South Africa | Investigational Site Number 012 | Amanzimtoti | |
| South Africa | Investigational Site Number 55 | Benoni | |
| South Africa | Investigational Site Number 11 | Bloemfontein | |
| South Africa | Investigational Site Number 21 | Cape Town | |
| South Africa | Investigational Site Number 22 | Cape Town | |
| South Africa | Investigational Site Number 26 | Cape Town | |
| South Africa | Investigational Site Number 27 | Cape Town | |
| South Africa | Investigational Site Number 13 | Durban | |
| South Africa | Investigational Site Number 14 | Durban | |
| South Africa | Investigational Site Number 32 | East London | |
| South Africa | Investigational Site Number 24 | George | |
| South Africa | Investigational Site Number 12387 | Johannesburg | |
| South Africa | Investigational Site Number 51 | Johannesburg | |
| South Africa | Investigational Site Number 47 | Klerksdorp | |
| South Africa | Investigational Site Number 43 | Nelspruit | |
| South Africa | Investigational Site Number 44 | Polokwane | |
| South Africa | Investigational Site Number 31 | Port Elizabeth | |
| South Africa | Investigational Site Number 41 | Pretoria | |
| South Africa | Investigational Site Number 42 | Pretoria | |
| South Africa | Investigational Site Number 451 | Pretoria | |
| South Africa | Investigational Site Number 48 | Rustenburg | |
| South Africa | Investigational Site Number 54 | Sandton | |
| South Africa | Investigational Site Number 25 | Somerset West | |
| South Africa | Investigational Site Number 56 | Vereeniging |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | Yes | |
| Secondary | 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 | No |