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 (ORL03)

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.

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer
• Intervention / Treatment: Drug: Cabazitaxel

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75231
    • Institut Curie
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cabazitaxel; All patients are treated with Cabazitaxel.	Drug: Cabazitaxel; 25 mg/m2 every 3 weeks by IV administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: UNICANCER

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): May 27, 2014

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cabazitaxel; recurrent or metastatic head and neck cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Head and Neck Neoplasms; Recurrence
• Other Study ID Numbers: UC-0130/1106; 2011-004712-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared at an individual level, those data will be part of the study database including all enrolled patients.