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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01620242
First received: May 24, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Head and Neck Cancer
Metastatic Head and Neck Cancer
Drug: Cabazitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • non-progression at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • progression free survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Toxicity according to NCI-CTCAE v4.0 [ Time Frame: from the first dose up to 30 days after the last dose ] [ Designated as safety issue: Yes ]
  • Quality of life evaluated by the QLQ-C30 and H&N35 questionnaire [ Time Frame: at the inclusion, at 6 weeks and at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cabazitaxel
    25 mg/m2 every 3 weeks by IV administration
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620242

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Centre Léon Berard
Lyon, France, 69008
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75231
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
UNICANCER
  More Information

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01620242     History of Changes
Other Study ID Numbers: UC-0130/1106
Study First Received: May 24, 2012
Last Updated: June 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UNICANCER:
recurrent or metastatic head and neck cancer
cabazitaxel

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014