Head and Neck Cancer Clinical Trial
Official title:
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 participant lead-in part: these 30 participants will receive
cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy
drugs [cisplatin or carboplatin plus 5-fluorouracil (5-FU)] administered every 3 weeks. After
18 weeks, participants who benefit from this treatment may continue to receive cetuximab
once-weekly until progression of the disease, an unacceptable side effect occurs,
participants withdraw consent, or the study is closed.
In the second part of this study, 200 participants will be randomized in 2 arms:
- 100 participants will receive commercial cetuximab manufactured by ImClone (Group A)
- 100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B).
All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin
plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this
treatment may continue to receive cetuximab once-weekly until progression of the disease, an
unacceptable side effect occurs, participants withdraw consent, or the study is closed.
n/a
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