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) - Full Text View

Sponsored by:	Merck KGaA
Information provided by:	EMD Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00122460

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 who did not receive prior chemotherapy. Overall survival will be taken as the primary measure of efficacy.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Cetuximab+Platinum (Cis or Carboplatin)+5FU Drug: Platinum (Cis or Carboplatin)+5FU	Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Carboplatin Cisplatin Fluorouracil Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by EMD Pharmaceuticals:

Primary Outcome Measures:

Overall Survival Time [ Time Frame: various timepoints ]

Secondary Outcome Measures:

Best overall response [ Time Frame: various timepoints ]
Disease control [ Time Frame: various timepoints ]
Duration of response [ Time Frame: various timepoints ]
Time to treatment failure [ Time Frame: various timepoints ]
Progression-free survival time [ Time Frame: various timepoints ]
Safety [ Time Frame: various timepoints ]
Quality of life assessments [ Time Frame: various timepoints ]

Enrollment:	442
Study Start Date:	December 2004
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: Cetuximab+Platinum (Cis or Carboplatin)+5FU Subjects in Group A will receive initial dose of 400 mg/m2 (over 2 hours) followed by weekly doses of 250 mg/m2 (over 1 hour). All doses will be given by IV infusionSubjects in both treatment groups (A nad B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks
2: Active Comparator	Drug: Platinum (Cis or Carboplatin)+5FU All doses will be given by IV infusion/Subjects in both treatment groups (A and B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks

Arms

Assigned Interventions

1: Experimental

Drug: Cetuximab+Platinum (Cis or Carboplatin)+5FU

Subjects in Group A will receive initial dose of 400 mg/m2 (over 2 hours) followed by weekly doses of 250 mg/m2 (over 1 hour). All doses will be given by IV infusionSubjects in both treatment groups (A nad B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks

2: Active Comparator

Drug: Platinum (Cis or Carboplatin)+5FU

All doses will be given by IV infusion/Subjects in both treatment groups (A and B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 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 and 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, 2650 Edegem, Department of Medical Oncology, Belgium

More Information

Publications indexed to this study:

Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27.

Study ID Numbers:	EMR 62202-002
Study First Received:	July 19, 2005
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00122460
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by EMD Pharmaceuticals:

Head and Neck Cancer

Study placed in the following topic categories:

Squamous cell carcinoma
Cetuximab
Carboplatin
Recurrence
Carcinoma
Epidermoid carcinoma
Cisplatin

Head and Neck Neoplasms
Fluorouracil
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009