A Study in Head and Neck Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Cetuximab; Drug: 5-Fluorouracil; Drug: Carboplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081041

I4E-MC-JXBD (Other Identifier)

13611

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 3 patient groups

Safety Lead-In (cetuximab manufactured by ImClone)

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: 5-Fluorouracil

Drug: Cisplatin

Drug: Cetuximab

Cetuximab manufactured by ImClone

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: 5-Fluorouracil

Drug: Cisplatin

Drug: Cetuximab

Cetuximab manufactured by Boehringer Ingelheim

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: 5-Fluorouracil

Drug: Cisplatin

Drug: Cetuximab