cetuximab, fluorouracil ( 5-FU) and cisplatin alone or with docetaxel in recurrent and/or metastatic head and neck cancer

• Conditions: Patients with first-line recurrent and/or metastatic SCCHN (stage III/IV) unsuitable for local therapies are eligible for this chemotherapy study.; MedDRA version: 14.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006923-30-DE
• Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-02
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

•Signed written informed consent
•Male or female > 18 years of age
•Histologically confirmed recurrent and/or metastatic stage III/IV SCCHN, not suitable for local therapy
•Patients with recurrent and/or metastatic SCCHN, who are not candidates for local therapies
•At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present
•ECOG Performance Status 0-1
•Adequate bone marrow function: leucocytes > 3.0 x 109/L, platelets > 80 x 109/L, hemoglobin > 10.0 g/dL
•Adequate liver function: Bilirubin < upper normal limit, SGOT, SGPT, AP, ?-GT < 3 x ULN
•Adequate renal function: serum creatinine < 1.5 mg/dl
•If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1) for the study duration and 2 months post-dosing

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior systemic treatment with cetuximab and docetaxel during the last 6 months
•Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
•Other serious illness or medical conditions:
-Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4;
-Significant neurologic or psychiatric disorders including dementia or seizures;
-Active uncontrolled infection;
-Active disseminated intravascular coagulation;
-Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
•Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if
due to trauma or mechanical impairment due to tumor mass
•Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
•Having participated in another clinical trial or having received any investigational agent 30 days before study entry
•Known allergic/hypersensitivity reaction to any of the components of the treatment
•Pregnancy (absence confirmed by serum/urine ?-HCG) or breast-feeding
•Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
•Legal incapacity or limited legal capacity
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
•Prior accommodation in an institution under officially or judicially orders (§40 p.1 No. 4 AMG)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •Progression-free survival ;Secondary Objective: •Objective Response Rate (CR + PR) according to the RECIST criteria<br>•Overall survival<br>•Toxicity<br>•Quality of life (EORTC QLQ C-30)<br>;Primary end point(s): The primary endpoint is to evaluate the progression-free survival. The primary endpoint progression-free survival is defined as the time from randomization to the first radiological confirmation of disease progression, or death from any cause within 60 days after the last assessment or randomization, whichever comes first.;Timepoint(s) of evaluation of this end point: n=20/per arm 1. Interim analysis for toxicity<br>n=40/per arm 2. Interim analysis for toxicity<br>n=50/per arm 3. Interim analysis for response<br>n=90/per arm Full analysis of all endpoints<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Objective Response Rate (CR + PR) according to the RECIST criteria<br>•Overall survival<br>•Toxicity<br>•Quality of life (EORTC QLQ C-30)<br>;Timepoint(s) of evaluation of this end point: see E.5.1.1