Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas of the Head and Neck

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Locally advanced squamous cell carcinomas of head and neck Read More

Inclusion Criteria:

• must have a non-resectable cancer of head and neck
• must have a pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx or cancer of unknown primary site
• must have a stage III or IV disease with an expected survival time 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 at the time of screening
• must be between ≥18 and ≤80 years of age
• must have the following laboratory values:

Analysis/International System of Units (SI units) Neutrophil count/≥ 1.5 G/l Platelet count/≥ 100 G/l Serum glutamate oxaloacetate transaminase (SGOT)/≤ 2 x the upper limit of normal Serum glutamate pyruvate transaminase (SGPT)/≤ 2 x the upper limit of normal Serum creatinine or estimated creatinine clearance/≤ 1.5mg/dl or Epidermal growth factor receptor (eGFR)≥ 50 ml/min/1.73m² Serum calcium/Within normal limits

• must be disease free from a previously treated malignancy for more than three years
• must provide a signed and dated written informed consent

• Female subject 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 interruption, 4 weeks before starting study drug, throughout study drug therapy (including 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; vasectomy 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 venous thromboembolism (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 milli-International units (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 subject must:

  • Agree to use condoms throughout study drug therapy, during any dose interruption and for up to 3 months after cessation of study therapy if his 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.

Exclusion Criteria:

• Evidence of distant metastatic disease
• Prior systemic chemotherapy within the last three years
• Previous surgery for the tumor under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx
• Prior radiation therapy to the head and neck
• Receiving radiation therapy as part of a postoperative regimen following primary surgical resection
• Pregnancy or breastfeeding
• Patient received prior Cetuximab or murine monoclonal antibody therapy
• Patient received prior Mitomycin-C and 5-Fluorouracil
• Actual hemorrhages
• Stomatitis, ulcerations in the mouth and the gastrointestinal tract
• Actual severe diarrhea
• Severe infectious diseases (Hepatitis A, B, C, D HIV)
• Coagulation disorders
• Active vaccination
• Patient has a medical or psychological condition that would not permit the patient to complete the trial or sign the informed consent
• Active participation in another clinical trial