Clinical trial for patients with squamous cell carcinoma of the head and neck in palliative situation.
- Conditions
- To evaluate the efficacy of cabazitaxel in patients with palliative head and neck previously treated with platinum-based therapy.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001938-42-BE
- Lead Sponsor
- Cliniques universitaires Saint-Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 98
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 <1 time the upper limit of normal (ULN) for age, serum alanine aminotransferase (ALT) < 1.5 ´ ULN for age, aspartate aminotransferase (AST) < 1.5 ´ ULN for age , serum creatinine <1.5 x ULN for age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
;
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 <1 time the upper limit of normal (ULN) for age, serum alanine aminotransferase (ALT) < 1.5 ´ ULN for age, aspartate aminotransferase (AST) < 1.5 ´ ULN for age , serum creatinine <1.5 x ULN for age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
;
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 <1 time the upper limit of normal (ULN) for age, serum alanine aminotransferase (ALT) < 1.5 ´ ULN for age, aspartate aminotransferase (AST) < 1.5 ´ ULN for age , serum creatinine <1.5 x ULN for age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
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 < 5years, as other than SCCHN.
9.Previous treatments with taxanes and/or anti-EGFR therapy are not an exclusion criteria.
10.Active grade > 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.
;
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 < 5years, as other than SCCHN.
9.Previous treatments with taxanes and/or anti-EGFR therapy are not an exclusion criteria.
10.Active grade > 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.
;
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 < 5years, as other than SCCHN.
9.Previous treatments with taxanes and/or anti-EGFR therapy are not an exclusion criteria.
10.Active grade > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method