Squamous cell cancer of head and neck, unresectable, locally advanced, Stage III/IVa or b (UICC, 2002) MedDRA version: 14.0 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
CAS Number: 205923-56-4
Current Sponsor code: Cetuximab
Other descriptive name: CET
Concentration unit: mg
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with histologically confirmed unresectable SCC of the oral cavity (no lip), oropharynx, hypopharynx or larynx (stage III/IVa or b) •Unidimensionally measurable lesion •Signed informed consent •Karnofsky PS = 70% •Age = 18 and = 70 •Curative treatment intent •Negative serum or urine pregnancy test (women of childbearing potential) •Adaequate bone marrow, hepatic and renal function (for further details see section 5 study protocol) 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 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 86
Exclusion criteria
Exclusion criteria: •Unknown primary cancer, nasopharynx cancer or salivary gland cancer •Metastatic disease •Another cancer within 5 years of study entry •Serious concomitant disease or medical condition •Pregnancy or lactation •Women of child-bearing potential with unclear contraception •Previous treatment with chemotherapy, radiotherapy or surgery in head and neck •Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening •Life expectancy < 3 months •Contraindications to receive cisplatin or cetuximab •Previous exposure to monoclonal antibodies and/or EGFR-targeted therapy •Social situations that limit the compliance with study requirements (for further details see section 5 study protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of feasibility, efficacy and safety of cetuximab (CET) combined with cisplatin (CIS) and hyperfractionated, accelerated radiotherapy (HART) as a treatment option with curative intent for patients with locally advanced, unresectable SCCHN. Phase I: defining the maximum tolerated dose (MTD) of a short infusion of cisplatin in the combined-modality treatment with cetuximab Phase II: Efficacy of combined-modality treatment with regards to progression-free survival. The dose of cisplatin in this combined-modality treatment will be determined in the phase I study. ;Secondary Objective: Phase I: Examining the dose limiting toxicities (DLT) of a short infusion of cisplatin in the combined-modality treatment with cetuximab. Phase II: Feasibility, efficacy and safety of combined-modality treatment with regards to overall survival, progression-free survival and tumor response. Evaluation of toxicity of HART-CIS-CET. ;Primary end point(s): Phase I: Determination of maximum tolerated dose (MTD) of cisplatin in HART-CIS-CET measured as maximum tolerated dose of cisplatin (mg/m2) Phase II: Determination of 2-year progression-free survival (PFS), as measured by the 2-year progression-free survival rate.;Timepoint(s) of evaluation of this end point: Phase I: following each administration and 8 weeks after the last administration. Phase II: 2 years after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression-free survival as measured by 1- and 5-year progression-free survival rates - Overall survival (OS) as measured by 1-, 2- and 5-year overall survival rates - Loco-regional progression-free survival (LPFS) as measured by 1-, 2- and 5-year loco-regional progression-free rate - Objective tumor response rate (ORR) (according to RECIST) - Toxicity of HART-CIS-CET (according CTCAE, version 3.0) ;Timepoint(s) of evaluation of this end point: - Toxicity: following each administration and 8 weeks after the last administration; off-treatment every 6 months (year 1-2) and every 12 months (year 3-5) up to disease progression - PFS: 1-, 2- and 5-year after start of therapy - ORR: 8 weeks after end of therapy followed by every 6 months (year 1-2), every 12 months (year 3-5) up to disease progression - Loco-regional progression-free survival (LPFS): measured 1-, 2- and 5-year after start of therapy | — |
Countries
Germany
Contacts
Public ContactKoordinierungszentrum für Klinische
Martin-Luther-Universität Halle-Wittenberg
Outcome results
None listed