Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments cetuximab, cisplatin, carboplatin, 5-fluorouracil
Phase phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date July 2010
End date August 2013
Trial size 187 participants
Trial identifier NCT01081041, 13611, I4E-MC-JXBD

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(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.
cetuximab Erbitux
Administered intravenously
cisplatin
Administered intravenously
carboplatin
Administered intravenously
5-fluorouracil 5-FU
Administered intravenously
(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.
cetuximab Erbitux
Administered intravenously
cisplatin
Administered intravenously
carboplatin
Administered intravenously
5-fluorouracil 5-FU
Administered intravenously
(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.
cetuximab Erbitux
Administered intravenously
cisplatin
Administered intravenously
carboplatin
Administered intravenously
5-fluorouracil 5-FU
Administered intravenously

Primary Outcomes

Measure
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013
time frame: 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
time frame: Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Parts 1 and 2: Randomization to date of death from any cause
Progression-Free Survival (PFS)
time frame: Parts 1 and 2: Randomization to the first date of objective progression of disease or death from any cause
Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR)
time frame: Parts 1 and 2: Randomization to progression of disease
Anti-Cetuximab Antibodies
time frame: Parts 1 and 2: Day 1 of Week 1 in Cycles 1, 3, and 5, and 30 days post treatment discontinuation
Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD)
time frame: Parts 1 and 2: Randomization to progression of disease
Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m^2 Cetuximab Dosing
time frame: Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose
Cmax of Cetuximab at Steady State
time frame: Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose
Area Under the Concentration Curve (AUC) of Cetuximab at Steady State
time frame: Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.