Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013
September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.
Part 2: Baseline to end of combination therapy (up to 18 weeks)
Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013
January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.
Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)

Secondary Outcomes (8)

Overall Survival (OS)
Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)
Progression-Free Survival (PFS)
Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)
Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)
Number of Participants With Anti-Cetuximab Antibodies
Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).
Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)
Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)
+3 more secondary outcomes

Study Arms (3)

Safety Lead-In (cetuximab manufactured by ImClone)

EXPERIMENTAL

Cycle 1: Week 1 - Cetuximab 400 milligrams per square meter (mg/m\^2) on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin area under the curve (AUC) 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m\^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

Drug: CetuximabDrug: CisplatinDrug: CarboplatinDrug: 5-Fluorouracil

Cetuximab manufactured by ImClone

EXPERIMENTAL

Cycle 1: Week 1 - Cetuximab 400 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m\^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

Drug: CetuximabDrug: CisplatinDrug: CarboplatinDrug: 5-Fluorouracil

Cetuximab manufactured by Boehringer Ingelheim

EXPERIMENTAL

Cycle 1: Week 1 - Cetuximab 400 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m\^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

Drug: CetuximabDrug: CisplatinDrug: CarboplatinDrug: 5-Fluorouracil

Interventions

CetuximabDRUG

Administered intravenously

Also known as: Erbitux, LY2939777

Cetuximab manufactured by Boehringer IngelheimCetuximab manufactured by ImCloneSafety Lead-In (cetuximab manufactured by ImClone)

CisplatinDRUG

Administered intravenously

Cetuximab manufactured by Boehringer IngelheimCetuximab manufactured by ImCloneSafety Lead-In (cetuximab manufactured by ImClone)

CarboplatinDRUG

Administered intravenously

Cetuximab manufactured by Boehringer IngelheimCetuximab manufactured by ImCloneSafety Lead-In (cetuximab manufactured by ImClone)

5-FluorouracilDRUG

Administered intravenously

Also known as: 5-FU

Cetuximab manufactured by Boehringer IngelheimCetuximab manufactured by ImCloneSafety Lead-In (cetuximab manufactured by ImClone)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.