Locally advanced squamous cell carcinomas of head and neck
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Current Sponsor code: Erbitux
Concentration unit: mg/ml mill
Sponsors
Medizinische Universität Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • must have a non non-resectable cancer of head and neck • must have pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, larynx or cancer of unknown primary site. • must have stage III or IV disease with an expected survival of = 12 months with node status of N0-N2 • must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy • must have a Karnofsky performance status (KPS) of = 70 • must be age between =18 and =80 years of age • must have the following laboratory values: Neutrophilcount = 100/uL = 1.5 x 109/L Platelet count = 80,000/uL = 100 x 1012 /L Bilirubin = 1.5 mg/dL = 25µ M/L SGOT = 2 x the upper limit of normal = 2 x the upper limit of normal SGPT = 2 x the upper limit of normal = 2 x the upper limit of normal Serum creatinine or estimated creatinine clearance =1.5mg/Dl = 50 mL/min = 133µ M/L = 50 mL/min Serum calcium Within normal limits Within normal limits • must be disease free from a previously treated malignancy for greater more than three years • a history of a previous basal basal cell carcinoma of the skin or pre-invasiv carcinoma of the cervix are no exclusion criteria • must provide signed and dated written informed consent • Female subjects of childbearing potential must: - Understand that the study medication could have an expected teratogenic risk - Agree to use, and be able to comply with, effective contraception without inter-ruption, 4 weeks before starting study drug, throughout study drug therapy (in-cluding dose interruptions) and for 3 months after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception* Implant Levonorgestrel-releasing intrauterine system (IUS) Medroxyprogesterone acetate depot Tubal sterilisation Sexual intercourse with a vasectomised male partner only; vasec-tomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel) * Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception. - Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. - Agree to have a medically supervised pregnancy test every 4 weeks including 3 months after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence • Male subjects must: - Agree to use condoms throughout study drug therapy, during any dose interruption and for 3 months after cessation of study therapy if their partner is of childbearing potential and has no contraception. - Agree not to donate semen during study drug therapy and for one week after end of study drug therapy. Are the trial subjects under 18? no Number of subjec
Exclusion criteria
Exclusion criteria: • have evidence of distant metastatic disease • have received prior systemic chemotherapy within the last three years • have undergone previous surgery for the tumour under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx • have received prior radiation therapy to the head and neck • be receiving radiation therapy as part of a postoperative regimen follow-ing primary surgical resection • be pregnant or breast feeding • have received prior Cetuximab or murine monoclonal antibody therapy • have received prior Mitomycin-C and 5-FU • have actual hemorrhages • have stomatitis, ulcerations in the mouth and the gastrointestinal tract • have actual severe diarrhea • have severe infectious diseases (e.g. Hepatitis A, B, C, D and/or HIV) • have coagulation disorders • have active vaccination • have medical or psychological condition that would not permit the patient to complete the trial or sign informed consent • have an active participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that Cetuximab combined with radiation therapy has a higher life quality compared to 5-FU/MMC plus radiation therapy, because of decreased side effects.;Secondary Objective: The secondary objective of the study are to evaluate: - Efficacy of Cetuximab plus radiation therapy - Equality in therapy of Cetuximab plus radiation therapy versus 5-FU/MMC plus radiation therapy.;Primary end point(s): The primary endpoint of the study is to examine the quality of life, based on differences in acute and late side effects.;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study are: • to determine the differences in response rates. • to examine differences in the rate of locoregional disease control, maintained for one year. ;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Austria
Contacts
Public ContactOE Clinical Trial Center
Medical University of Innsbruck
Outcome results
None listed