To evaluate the efficacy of cabazitaxel in patients with palliative head and neck previously treated with platinum-based therapy.
Conditions
Interventions
Trade Name: JEVTANA
Product Name: CABAZITAXEL
Product Code: XRP6258
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Jevtana
CAS Number: 183133-96-2
Other desc
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation. 2. At least one measurable lesion by MRI or CT-scan according to RECIST 1.1. 3. Progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting. 4. ECOG performance status 0 -2, in stable medical condition 5. Patients must have an expected survival of at least 3 months. 6. Patients must be over 18 years old and must be able to give written informed consent (signed prior to beginning protocol specific procedure). 7. Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment). 8. Patients must have adequate organ function (Hemoglobin = 9 g/100 ml, Neutrophils = 1,500/mm3, Platelets = 100,000/mm3, total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 18 ;Inclusion criteria: 1. Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation. 2. At least one measurable lesion by MRI or CT-scan according to RECIST 1.1. 3. Progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting. 4. ECOG performance status 0 -2, in stable medical condition 5. Patients must have an expected survival of at least 3 months. 6. Patients must be over 18 years old and must be able to give written informed consent (signed prior to beginning protocol specific procedure). 7. Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment). 8. Patients must have adequate organ function (Hemoglobin = 9 g/100 ml, Neutrophils = 1,500/mm3, Platelets = 100,000/mm3, total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 18 ;Inclusion criteria: 1. Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation. 2. At least one measurable lesion by MRI or CT-scan according to RECIST 1.1. 3. Progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting. 4. ECOG performance status 0 -2, in stable medical condition 5. Patients must have an expected survival of at least 3 months. 6. Patients must be over 18 years old and must be able to give written informed consent (signed prior to beginning protocol specific procedure). 7. Women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment). 8. Patients must have adequate organ function (Hemoglobin = 9 g/100 ml, Neutrophils = 1,500/mm3, Platelets = 100,000/mm3, total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Non-squamous head and neck cancer 2. Nasopharynx cancer 3. More than two lines of chemotherapy for palliative treatment 4. Surgery or investigational drugs or chemotherapy within 4 weeks before study inclusion. For irradiation, if palliative (i.e 8 Gy on a painful lesion) no delay is needed and for curative radiotherapy (65-70 Gy) a delay of 8 weeks minimum is needed or until recovery of any major event related to RT. 5. Previous treatment with cabazitaxel 6. Significant active cardiac disease including: uncontrolled high blood pressure according to the CTCAE 4 grading, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias 7. Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …) 8. Previous malignancy from which the patient has been disease-free for 2 peripheral neuropathy 11. Active grade > 2 stomatitis 12. Known brain or leptomeningeal involvement 13. History of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs 14. Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A/5. A one-week washout period is necessary for patients who are already on these treatments. 15. Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up. ;Exclusion criteria: 1. Non-squamous head and neck cancer 2. Nasopharynx cancer 3. More than two lines of chemotherapy for palliative treatment 4. Surgery or investigational drugs or chemotherapy within 4 weeks before study inclusion. For irradiation, if palliative (i.e 8 Gy on a painful lesion) no delay is needed and for curative radiotherapy (65-70 Gy) a delay of 8 weeks minimum is needed or until recovery of any major event related to RT. 5. Previous treatment with cabazitaxel 6. Significant active cardiac disease including: uncontrolled high blood pressure according to the CTCAE 4 grading, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias 7. Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …) 8. Previous malignancy from which the patient has been disease-free for 2 peripheral neuropathy 11. Active grade > 2 stomatitis 12. Known brain or leptomeningeal involvement 13. History of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs 14. Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A/5. A one-week washout period is necessary for patients who are already on these treatments. 15. Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up. ;Exclusion criteria: 1. Non-squamous head and neck cancer 2. Nasopharynx cancer 3. More than two lines of chemotherapy for palliative treatment 4. Surgery or investigational drugs or chemotherapy within 4 weeks before study inclusion. For irradiation, if palliative (i.e 8 Gy on a painful lesion) no delay is needed and for curative radiotherapy (65-70 Gy) a delay of 8 weeks minimum is needed or until recovery of any major event related to RT. 5. Previous treatment with cabazitaxel 6. Significant active cardiac disease including: uncontrolled high blood pressure according to the CTCAE 4 grading, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias 7. Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …) 8. Previous malignancy from which the patient has been disease-free for 2 peripheral neuropathy 11. Active grade > 2 stomatitis 12. Known brain or leptomeningeal involvement 13. History of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs 14. Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A/5. A one-week washout period is necessary for patients who are already on these treatments. 15. Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event (CTC-NCI version 4). 2. Objective tumor response (according to RECIST) 3. Time to progression (TTP) defined as the time from randomization until disease progression 4. Progression-free survival defined as the time from randomization until disease progression or death 5. Overall survival defined as the time from randomization until date of death from any cause ;Primary end point(s): 1. Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks (defined as the proportion of patients alive and free of progression at 18 weeks);Timepoint(s) of evaluation of this end point: 18 weeks;Main Objective: 1. Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks (defined as the proportion of patients alive and free of progression at 18 weeks);Secondary Objective: 1. Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event (CTC-NCI version 4). 2. Objective tumor response (according to RECIST) 3. Time to progression (TTP) defined as the time from randomization until disease progression 4. Progression-free survival defined as the time from randomization until disease progression or death 5. Overall survival defined as the time from randomization until date of death from any cause ;Primary end point(s): 1. Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks (defined as the proportion of patients alive and free of progression at 18 weeks);Timepoint(s) of evaluation of this end point: 18 weeks;Main Objective: 1. Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks (defined as the proportion of patients alive and free of progr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event 2. Objective tumor response (according to RECIST) 3. Time to progression (TTP) defined as the time from randomization until disease progression 4. Progression-free survival defined as the time from randomization until disease progression or death 5. Overall survival defined as the time from randomization until date of death from any cause;Timepoint(s) of evaluation of this end point: 1. Safety will be determined after each injection 2 +3. After each evaluation after 3 cycles, every 9 weeks 4+5. depending of the evolution of the disease;Secondary end point(s): 1. Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event 2. Objective tumor response (according to RECIST) 3. Time to progression (TTP) defined as the time from randomization until disease progression 4. Progression-free survival defined as the time from randomization until disease progression or death 5. Overall survival defined as the time from randomization until date of death from any cause;Timepoint(s) of evaluation of this end point: 1. Safety will be determined after each injection 2 +3. After each evaluation after 3 cycles, every 9 weeks 4+5. depending of the evolution of the disease;Secondary end point(s): 1. Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event 2. Objective tumor response (according to RECIST) 3. Time to progression (TTP) defined as the time from randomization until disease progression 4. Progression-free survival defined as the time from randomization until disease progression or death 5. Overall survival defined as the time from randomization until date of death from any cause;Timepoint(s) of evaluation of this end point: 1. Safety will be determined after each injection 2 +3. After each evaluation after 3 cycles, every 9 weeks 4+5. depending of the evolution of the disease | — |
Countries
Belgium
Contacts
Public ContactCentre du Cancer;Centre du Cancer;Centre du Cancer ;;
Cliniques universitaires Saint-Luc;Cliniques universitaires Saint-Luc;Cliniques universitaires Saint-Luc
Outcome results
None listed