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

NCT ID: NCT01528163

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-11-30

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

Cabazitaxel (XRP6258) is a new taxoid, which promotes tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel

Group Type: EXPERIMENTAL

Cabazitaxel

Intervention Type: DRUG

from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.

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.

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.

Interventions

Cabazitaxel

from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.

Intervention Type: DRUG

Methotrexate

From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.

Intervention Type: DRUG

Other Intervention Names

Jevtana; Emthexate

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pascal Machiels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre du Cancer, Cliniques universitaires Saint-Luc

Locations

Clinique Saint-Pierre

Ottignies, Brabant Wallon, Belgium

Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale

Brussels, Brussels Capital, Belgium

RHMS Baudour

Baudour, Hainaut, Belgium

Grand Hôpital de Charleroi

Charleroi, Hainaut, Belgium

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, Belgium

CHU Tivoli Centre René Goffin

La Louvière, Hainaut, Belgium

CHU Ambroise PARE

Mons, Hainaut, Belgium

CHU de Charleroi site Vésale

Montigny-le-Tilleul, Hainaut, Belgium

Centre Hospitalier Wallonie Picarde

Tournai, Hainaut, Belgium

CHU de Mont Godinne

Yvoir, Namur, Belgium

Universitair Ziekenhuis Brussel (Campus Jette)

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

CHR Citadelle

Liège, , Belgium

CHU de Liège Sart Tilman

Liège, , Belgium

Clinique et Maternité Sainte-Elisabeth

Namur, , Belgium

Centre Hospitalier de Luxembourg

Luxembourg, , Luxembourg

Countries

Belgium; Luxembourg

References

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. doi: 10.1634/theoncologist.2016-0296. Epub 2016 Nov 30.

Reference Type: DERIVED

PMID: 27903924 (View on PubMed)

Other Identifiers

2011-001938-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UCL-ONCO 2011-01

Identifier Type: -

Identifier Source: org_study_id