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)
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00122460
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cetuximab Plus Chemotherapy Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) - Chemotherapy alone Platinum (Cisplatin or Carboplatin) + 5-FU -
- Primary Outcome Measures
Name Time Method Overall Survival Time (OS) time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Time (PFS) time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.Best Overall Response evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).
Disease Control evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria).
Time to Treatment Failure Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment.Duration of Response time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007 Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007 Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.
Safety - Number of Patients Experiencing Any Adverse Event time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007 Please refer to Adverse Events section for further details
Trial Locations
- Locations (1)
Research Site
🇬🇧Nottingham, United Kingdom