Phase 2
N=187
A Study in Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01081041 ↗Enrolled (actual)
187
Serious AEs
60.8%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013 — 76; 68 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Drug); Cisplatin (Drug); Carboplatin (Drug); 5-Fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013 |
76; 68 | — |
| PRIMARY Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013 |
75; 68 | — |
| SECONDARY Overall Survival (OS) |
9.13; 9.23; 9.46 | — |
| SECONDARY Progression-Free Survival (PFS) |
4.57; 4.34; 5.59 | — |
| SECONDARY Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) |
24.2; 32.5; 36.6 | — |
| SECONDARY Number of Participants With Anti-Cetuximab Antibodies |
4 | — |
| SECONDARY Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR) |
69.7; 58.4; 62.0 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing |
208; 208 | — |
| SECONDARY Cmax of Cetuximab at Steady State |
225; 199 | — |
| SECONDARY Area Under the Concentration Curve (AUC) of Cetuximab at Steady State |
21900; 18800 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01081041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.