Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab in Combination With Paclitaxel and Carboplatin for Treatment of Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Unknown status
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary 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

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cetuximab; Cisplatin; Paclitaxel

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.

• Clinical examination

• 1 unidimensional lesion according to RECIST 1.1.

• 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

• Written informed consent must be obtained according to the local Ethics committee.

Exclusion Criteria:

• > 75 years

• Nasopharyngeal cancer and cancer of the paranasal sinuses

• Inability to follow the treatment and evaluation schedule

• 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 male or female 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

• Known hypersensitivity to any of the components of the treatment

• Legal incapacity

• Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.

• Patients with clinically relevant neuropathy

• Previously treated for relapsed or metastatic SCCHN except radiotherapy for previously treated relapse if terminated > 3 months before start of treatment.

• Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.