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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— RACATREX  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528163
• Other study ID #: UCL-ONCO 2011-01
• Secondary ID: 2011-001938-42
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2012
• Last updated: June 12, 2017
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2017
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Cabazitaxel
from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.
• Methotrexate
From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.

Locations

Country	Name	City	State
Belgium	RHMS Baudour	Baudour	Hainaut
Belgium	Universitair Ziekenhuis Brussel (Campus Jette)	Brussel
Belgium	Cliniques universitaires Saint-Luc, Centre du Cancer, Oncologie Médicale	Brussels	Bruxelles Capitale
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Hôpital de Jolimont	Haine-Saint-Paul	Hainaut
Belgium	CHU Tivoli Centre René Goffin	La Louvière	Hainaut
Belgium	CHR Citadelle	Liège
Belgium	CHU de Liège Sart Tilman	Liège
Belgium	CHU Ambroise PARE	Mons	Hainaut
Belgium	CHU de Charleroi site Vésale	Montigny-Le-Tilleul	Hainaut
Belgium	Clinique et Maternité Sainte-Elisabeth	Namur
Belgium	Clinique Saint-Pierre	Ottignies	Brabant Wallon
Belgium	Centre Hospitalier Wallonie Picarde	Tournai	Hainaut
Belgium	CHU de Mont Godinne	Yvoir	Namur
Luxembourg	Centre Hospitalier de Luxembourg	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Determine the efficacy of cabazitaxel in patients with head and neck cancer in terms of progression-free survival rate at 18 weeks.	18 weeks
Secondary	Safety profile	Determine the safety profile of cabazitaxel in patients with head and neck cancer: adverse event	18 weeks