These phase II studies evaluate the pharmacokinetics, or effects on your body from medications, and drug-drug interaction of cetuximab and cisplatin or cetuximab and carboplatin in patients with recurrent or metastatic carcinoma of the head and neck.
Raymond Perez, MD
A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone Versus Boehringer Ingelheim Manufacturing Processes, in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients With Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
This study will begin with a 30-patient lead-in part: these 30 patients will receive cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs (cisplatin or carboplatin plus 5-fluorouracil) administered every 3 weeks. After 18 weeks, patients who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, patients withdraw consent or the study is closed.
In the second part of this study, 200 patients will be randomized in 2 arms:
- 100 patients will receive commercial cetuximab manufactured by ImClone (Group A)
- 100 patients will receive cetuximab manufactured by Boehringer Ingelheim (Group B)
All these 200 patients will receive other chemotherapy drugs (cisplatin or carboplatin plus 5-fluorouracil) administered every 3 weeks. After 18 weeks, patients who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, patients withdraw consent or the study is closed.
Ages eligible for study:
18 Years and older
Genders eligible for study:
Accepts healthy volunteers:
- Head and neck cancer that was confirmed by tissue or cell biopsy
- Disease not suitable for local therapy
- Measurable or evaluable disease
- Karnofsky performance status, or KPS, score of at least 70
- Organs are functioning well - bone marrow reserve, liver and kidney
- Life expectancy of at least 12 weeks
- Signed informed consent document
- Receiving another investigational medication within the last 30 days
- Prior chemotherapy, except if given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
- Nasopharyngeal carcinoma
- Previous treatment with monoclonal antibody therapy or other signal transduction inhibitors or EGFR targeting therapy except for prior cetuximab treatment given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry
- Uncontrolled high blood pressure
- Heart disease or had a heart attack within the last year
- Currently have an infection that requires for you to take an IV antibiotic
- Currently receiving other therapies for your cancer, such as chemotherapy, radiation therapy, immunotherapy and hormonal therapy
- Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
- Known drug abuse (with the exception of alcohol abuse)
- Known allergic reaction against any of the components of the study treatment
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Have had another type of cancer within the last 2 years
- You are currently pregnant or breastfeeding
- You are considering becoming pregnant or fathering a child
Get more information on this clinical trial.