Patients with relapsed or metastatic squamous cell carcinoma of the head and neck Previously not treated for relapsed or metastatic SCCHN.
Conditions
Interventions
Trade Name: Erbitux
Product Name: cetuximab
Pharmaceutical Form:
Sponsors
Radiumhemmet Karolinska University Hospital
Radiumhemmet
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy;Secondary Objective: To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and neck the following study variables between both treatment arms: • Best overall response • Duration of response • Time to treatment failure • Overall survival • Safety ;Primary end point(s): patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether the PFS rate in the arm with cetuximab combined with carboplatin and paclitaxel based chemotherapy is not markedly worse than PFS in the arm with cetuximab combined with cisplatin and 5-FU based chemotherapy;Timepoint(s) of evaluation of this end point: Progression free survival is defined as the period from randomization until first observation of PD, or death due to any cause. This will be assessed by MRI or CT at baseline, after cycle 2, 4 and 6 and thereafter every 3rd month during 2 years post randomization and thereafter every 6 month until 3 years post randomization, or progressive disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Best overall response Duration of response Time to treatment failure Overall survival Safety ;Timepoint(s) of evaluation of this end point: Overall response, in months will be determined for patients whose best response was either CR or PR Duration of response, in months will determined for patients whose best response was either CR or PR. It is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death. If a patient has not had PD, then the duration of response will be censored on the date of last known tumor assessment. Time to treatment failure;the time in months from randomization until the date of the first occurrence of one of the events defining treatment failure. Overall survival;the time from the day of randomization to death from any cause. Safety and toxicity of the two treatments will be evaluated | — |
Countries
Denmark, Sweden
Outcome results
None listed