Randomised phase II study with cetuximab (Erbitux®) in combination with chemotherapy (5-FU and cisplatin or carboplatin) versus cetuximab (Erbitux®) in combination with chemotherapy (paclitaxel and carboplatin) for treatment of patients with relapsed or metastatic head and neck cancer

Phase 1

• Conditions: Patients with relapsed or metastatic squamous cell carcinoma of the head and neckPreviously not treated for relapsed or metastatic SCCHN.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022924-57-SE
• Lead Sponsor: Radiumhemmet Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-19
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

? > 18 years
? Histologically or cytologically confirmed SCCHN, relapsed and/or metastatic
Patient must have a life expectancy of at least 3 months allowing adequate follow-up toxicity evaluation.
At least 1 dimensionally measurable lesion either by CT scan or MRI or physical examination. PS WHO 0-1 at study entry
Adequate hematological function defined as WBC =3 x 109/litre and platelets =100 x 109/litre, ANC > 1.5 x 109/litre and Hb > 100 g/L
Adequate liver function: Bilirubin <1.5 x UNL, ALAT or ASAT <3,0 UNL, alkaline phosphates < 2.5 UNL
Creatinine clearance > 50mL/min when treated with Cisplatin
Written informed consent must be obtained according to the local Ethics committee.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

>75 years
Nasopharyngeal ca, and cancer of the paranasal sinuses
Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives
Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth-control
Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment.
Legal incapacity.
Clinically significant cardiovascular disease, , or history of myocardial infarction in the last 6 months.
Patients with clinically relevant neuropathy
Previously treated for relapsed or metastatic SCCHN except radiotherapy
Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified