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Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RACATREX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01528163
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Efficacy [ Time Frame: 18 weeks ]
Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01528163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
Safety profile [ Time Frame: 18 weeks ]
Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official Title  ICMJE Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Therapy.
Brief Summary In this clinical trial, the investigators want to know if cabazitaxel is more effective than methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head and neck in palliative treatment.
Detailed Description

The principal aim is to evaluate the efficacy of cabazitaxel in patients with palliative head and neck previously treated with platinum-based therapy.

The study design is a non comparative randomized phase II trial: ARM 1: cabazitaxel (20 mg/m2, every 3 weeks) versus ARM 2 methotrexate (40 mg/m2, weekly). Cabazitaxel dose will be increased to 25mg/m2 for the second and subsequent cycles, in the absence of non-hematological AE > grade 2 and hematological AE > grade 3 during the first cycle. (maximum 10 cycles). The aim of the randomization is to offer a valid internal control group by avoiding possible selection bias. However, results obtained in the two treatment group will not be formally compared as this is not the objective of a phase II study.

Tumor check-up will be performed every 9 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. A maximum of 10 cycles of cabazitaxel will be given.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: Cabazitaxel
    from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.
    Other Name: Jevtana
  • Drug: Methotrexate
    From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.
    Other Name: Emthexate
Study Arms  ICMJE
  • Experimental: Cabazitaxel
    Cabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel
    Intervention: Drug: Cabazitaxel
  • Active Comparator: Methotrexate

    Methotrexate is the historical control and has been widely used in SCCHN for palliation.

    This medication is an antimetabolite and antifolate drug. It acts by inhibiting the metabolism of folic acid.

    Intervention: Drug: Methotrexate
Publications * Machiels JP, Van Maanen A, Vandenbulcke JM, Filleul B, Seront E, Henry S, D'Hondt L, Lonchay C, Holbrechts S, Boegner P, Brohee D, Dequanter D, Louviaux I, Sautois B, Whenham N, Berchem G, Vanderschueren B, Fontaine C, Schmitz S, Gillain A, Schoonjans J, Rottey S. Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-Based Therapy. Oncologist. 2016 Dec;21(12):1416-e17. Epub 2016 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
101
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
98
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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. Paraffin-embedded tumor tissue available for immunohistochemistry but not mandatory
  7. Patients must be over 18 years old and must be able to give written informed consent.
  8. 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).
  9. 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 1.5 x ULN for age, aspartate aminotransferase (AST) < 1.5 ´ ULN for age , serum creatinine <1.5 x ULN for age.
  10. Signed informed consent prior to beginning protocol specific procedure.
  11. Sexually active patients must use effective contraception during the period of therapy and up to 150 days after the last treatment dose. Acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device)

Exclusion Criteria:

  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. Curative radiation therapy (60-70 Gy) within 8 weeks. For palliative radiation therapy (i.e 8 Gy on a painful lesion) no delay is needed.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Luxembourg
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528163
Other Study ID Numbers  ICMJE UCL-ONCO 2011-01
2011-001938-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Pascal Machiels, MD, PhD Centre du Cancer, Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP