A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes

NCT01620242 | Completed Phase 2 DMC

• 2 other identifiers: UC-0130/11062011-004712-32
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer

Keywords

recurrent or metastatic head and neck cancer; cabazitaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression free survival

  1-year

• Toxicity according to NCI-CTCAE v4.0

  from the first dose up to 30 days after the last dose

• Quality of life evaluated by the QLQ-C30 and H&N35 questionnaire

  at the inclusion, at 6 weeks and at the end of treatment

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

All patients are treated with Cabazitaxel.

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

25 mg/m2 every 3 weeks by IV administration

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic or recurrent Head and neck cancer
• Progression after cisplatin, cetuximab and taxanes (drugs could have been administered alone or in combination) given for recurrent/metastatic disease
• Age ≥ 18
• ECOG performance status ≤ 2
• At least one measurable lesion on CT-scan (as per RECIST criteria V1.1).
• Life expectancy ≥ 3 months
• 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).
• 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.
• 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.
• Patients must be affiliated to a Social Security System.
• Patient who have received the information sheet and signed the informed consent form.
• Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

You may not qualify if:

• Active concurrent malignancy
• Progression in the 3 months after the completion of treatment for localized disease
• 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).
• 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)
• Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the formulation including polysorbate 80
• Pregnant women, women who are likely to become pregnant or are breast-feeding.
• 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.
• Patients who received any other investigational drugs within the 14 days prior to the start of cabazitaxel.
• Patients receiving radiation within 4 weeks prior to the first dose of study drug.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (5)

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Berard

Lyon, 69008, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75231, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 15, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: May 27, 2014
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)