Status:
UNKNOWN
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
Lead Sponsor:
Karolinska University Hospital
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 carboplati...
Detailed Description
Recurrent and/or metastatic SCCHN patients are, by definition patients with recurrent disease and/or with newly diagnosed distant metastases, although this group of patients has a very heterogeneous d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01830556
Start Date
November 1 2011
End Date
November 1 2015
Last Update
May 21 2013
Active Locations (5)
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1
Lena Specht
Copenhagen, Denmark, 2100
2
Karolinska Universityhospital
Stockholm, Stockholm County, Sweden, 17176
3
Hedda Haugen
Gothenburg, Sweden, 413 45
4
Karin Söderström
Umeå, Sweden, 90189