Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: Platinum (Cisplatin or Carboplatin) + 5-FU; Drug: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00122460

EMR 62202-002

Details and patient eligibility

About

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.

Enrollment: 442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
• Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion criteria

• Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
• Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
• Nasopharyngeal carcinoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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442 participants in 2 patient groups

Cetuximab Plus Chemotherapy

Experimental group

Treatment:

Drug: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)

Chemotherapy alone

Active Comparator group

Treatment:

Drug: Platinum (Cisplatin or Carboplatin) + 5-FU