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A Study in Head and Neck Cancer

2014-08-27 03:15:25 | BioPortfolio

Summary

This study will begin with a 30 patients 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 randomize 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Head and Neck Cancer

Intervention

cetuximab, Cisplatin, Carboplatin, 5-fluorouracil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Tucson
Arizona
United States
85715

Status

Not yet recruiting

Source

Eli Lilly and Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:25-0400

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Medical and Biotech [MESH] Definitions

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