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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)

Primary Purpose

Neoplasms (no Otherwise Specified)

Status

Completed

Phase

Phase 4

Locations

South Africa

Study Type

Interventional

Intervention

LENOGRASTIM (GRANOGYTE 34)

About this trial

This is an interventional treatment trial for Neoplasms (no Otherwise Specified)

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)

Arm Description

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)

Outcomes

Primary Outcome Measures

Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Secondary Outcome Measures

Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Incidence and severity of asthenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Incidence and severity of anorexia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Incidence and severity of myalgia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Incidence and severity of nails changes, including nail disorders assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Incidence and severity of oral mucositis assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Neutropenia/febrile neutropenia associated days in hospital

Neutropenia/febrile neutropenia associated use of anti-infectives

Incidence of chemotherapy dose reduction, withdrawals or treatment delays due to neutropenia or febrile neutropenia

Infection with (or without) neutropenia

Relationship between the incidence and severity of neutropenia and the different chemotherapy regimens

Full Information

NCT ID

NCT01107756

First Posted

April 13, 2010

Last Updated

October 4, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01107756

Brief Title

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

Acronym

Grano-Tax

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 Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms (no Otherwise Specified)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

LENOGRASTIM (GRANOGYTE 34)

Intervention Description

Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4

Time Frame