Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-12-20

Brief Summary

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This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.

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Detailed Description

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Conditions

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Carcinoma, Squamous Cell of Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle.

Cisplatin/Carboplatin

Intervention Type DRUG

Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.

5-fluorouracil

Intervention Type DRUG

Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.

Cisplatin/Carboplatin + 5-Flurouracil

Group Type ACTIVE_COMPARATOR

Cisplatin/Carboplatin

Intervention Type DRUG

Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.

5-fluorouracil

Intervention Type DRUG

Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.

Interventions

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Cetuximab

Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle.

Intervention Type DRUG

Cisplatin/Carboplatin

Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.

Intervention Type DRUG

5-fluorouracil

Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.

Intervention Type DRUG

Other Intervention Names

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Erbitux 5-FU

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of SCCHN
* Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment
* Presence of at least 1 measurable lesion according to RECIST Version 1.1
* Signed written informed consent before any trial-related activities are carried out
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

* Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization
* Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry
* Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor
* Nasopharyngeal carcinoma
* Known central nervous system metastasis and/or leptomeningeal disease
* Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent
* Legal incapacity or limited legal capacity

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No