A Study in Head and Neck Cancer

Status:	Completed
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	June 2010
End Date:	September 2015

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.

Inclusion Criteria:

- Head and neck cancer that was confirmed by tissue biopsy or cytology

- Disease not suitable for local therapy

- Measurable or evaluable disease

- Karnofsky performance status (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

Exclusion Criteria:

- 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 epidermal growth factor receptor (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 participant 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

We found this trial at

sites

Clinical Trial Facility in Albany New York

Albany, New York 12205

from

Albany, NY