Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01620242
Other study ID # UC-0130/1106
Secondary ID 2011-004712-32
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2012
Est. completion date May 27, 2014

Study information

Verified date February 2021
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.


Description:

Patients will be treated with intravenous cabazitaxel 25 mg/m2 every 3 weeks (D1=D22) for 6 cycles. In absence of progression disease or unacceptable toxicity, the treatment could be continued until a maximum of 10 cycles. Disease response will be assessed every 6 weeks (i.e. every 2 cycles) clinically and by CT-scan. An interim analysis will be carried out after the inclusion of the first 10 eligible and assessable patients.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date May 27, 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Metastatic or recurrent Head and neck cancer 2. Progression after cisplatin, cetuximab and taxanes (drugs could have been administered alone or in combination) given for recurrent/metastatic disease 3. Age = 18 4. ECOG performance status = 2 5. At least one measurable lesion on CT-scan (as per RECIST criteria V1.1). 6. Life expectancy = 3 months 7. Adequate hematologic function (neutrophils = 1.5 x 109/L, platelets = 100 x 109/L; Hb = 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) = 60 mL/min) and hepatic function (serum bilirubin = 1 ULN; AST and ALT = 2.5 x ULN). 8. Potentially reproductive patients must agree to use an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 6 months after the final dose of investigational product. 9. Women of childbearing potential must have a negative serum beta-HCG pregnancy test within 14 days prior of enrolment and/or urine pregnancy test within 48 hours before the first administration of the study treatment. 10. Patients must be affiliated to a Social Security System. 11. Patient who have received the information sheet and signed the informed consent form. 12. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria: 1. Active concurrent malignancy 2. Progression in the 3 months after the completion of treatment for localized disease 3. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as : - infection, - cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2, - current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per investigator assessment), - renal disease, - active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded, - severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air). 4. Patients must have recovered of previous toxicity of chemotherapy and must not have toxicity grade > 1 ; grade = 2 for neuropathy and grade = 2 for cutaneous rash after cetuximab (in the CTCAE v4.0) 5. Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the formulation including polysorbate 80 6. Pregnant women, women who are likely to become pregnant or are breast-feeding. 7. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 8. Patients who received any other investigational drugs within the 14 days prior to the start of cabazitaxel. 9. Patients receiving radiation within 4 weeks prior to the first dose of study drug. 10. Patients already included in another therapeutic trial involving an experimental drug 11. Individual deprived of liberty or placed under the authority of a tutor. 12. Other primary tumors within the previous 3 years 13. Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one week wash-out period is necessary for patients who are already on these treatments.

Study Design


Intervention

Drug:
Cabazitaxel
25 mg/m2 every 3 weeks by IV administration

Locations

Country Name City State
France Centre Oscar Lambret Lille
France Centre Léon Berard Lyon
France Centre Antoine Lacassagne Nice
France Institut Curie Paris
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary non-progression at 6 weeks To assess the efficacy of cabazitaxel in terms of non-progression at 6 weeks for the treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.
Non-progression will be assessed after centralized review of CT-scans.
6 weeks
Secondary progression free survival 1-year
Secondary Toxicity according to NCI-CTCAE v4.0 from the first dose up to 30 days after the last dose
Secondary Quality of life evaluated by the QLQ-C30 and H&N35 questionnaire at the inclusion, at 6 weeks and at the end of treatment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05738187 - Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study N/A
Recruiting NCT02567383 - Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer Phase 2
Recruiting NCT05980000 - Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma Phase 2
Active, not recruiting NCT03691714 - Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Phase 2
Terminated NCT02842125 - Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Terminated NCT04969861 - BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36) Phase 2/Phase 3
Active, not recruiting NCT04260126 - Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC Phase 2
Completed NCT02358031 - A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) Phase 3
Completed NCT02422979 - Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer Phase 1/Phase 2
Completed NCT04902027 - A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers Phase 1
Recruiting NCT04534205 - A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 Phase 2
Active, not recruiting NCT02289209 - Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck Phase 2
Recruiting NCT06239220 - PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC Phase 2
Recruiting NCT04673929 - Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract
Recruiting NCT03754933 - Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer Phase 1/Phase 2
Terminated NCT03937141 - Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer Phase 2
Terminated NCT00088907 - Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer Phase 3
Terminated NCT01606566 - A Study to Evaluate the Safety and Efficacy of Amphinex Induced PCI of Bleomycin for Recurrent Head and Neck Cancer. Phase 2
Completed NCT01255800 - Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer Phase 1