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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00122460
First received: July 19, 2005
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
 Drug: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)
Drug: Platinum (Cisplatin or Carboplatin) + 5-FU
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cetuximab 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Overall Survival Time (OS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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:
  • Progression-free Survival Time (PFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 Frame: 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 ] [ Designated as safety issue: No ]

    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 Frame: 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 Frame: 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 ] [ Designated as safety issue: Yes ]
    Please refer to Adverse Events section for further details


Enrollment: 442
Study Start Date: December 2004
Study Completion Date: July 2011
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab Plus Chemotherapy Drug: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)
Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks
Active Comparator: Chemotherapy alone Drug: Platinum (Cisplatin or Carboplatin) + 5-FU
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122460

  Show 70 Study Locations
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Jan B. Vermorken, Prof. University Hospital Antwerpen, Department of Medical Oncology, 2650-Edegem, Belgium
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00122460     History of Changes
Other Study ID Numbers: EMR 62202-002
Study First Received: July 19, 2005
Results First Received: August 25, 2011
Last Updated: August 25, 2011
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Merck KGaA:
Head and Neck Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Cisplatin
Fluorouracil
 Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013