Clinical trial · Interventional
A Study in Head and Neck Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Safety Lead-In (cetuximab manufactured by ImClone)
- 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.
- interventionNames
- Drug: Cetuximab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: 5-Fluorouracil
- type
- EXPERIMENTAL
- label
- Cetuximab manufactured by ImClone
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSoulieres D, Aguilar JL, Chen E, Misiukiewicz K, Ernst S, Lee HJ, Bryant K, He S, Obasaju CK, Chang SC, Chin S, Adkins D. Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a randomized, double-blind safety study comparing cetuximab produced from two manufacturing processes using the EXTREME study regimen. BMC Cancer. 2016 Jan 14;16:19. doi: 10.1186/s12885-016-2064-0. PMID 26768732