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| Sponsor: | Merck KGaA |
|---|---|
| Information provided by: | Merck KGaA |
| 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 |
| 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 |
| Enrollment: | 442 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | July 2010 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 70 Study Locations| Principal Investigator: | Jan B. Vermorken, Prof. | University Hospital Antwerpen, 2650 Edegem, Department of Medical Oncology, Belgium |
More Information
| Responsible Party: | Merck KGaA ( Inmaculada Ollero ) |
| Study ID Numbers: | EMR 62202-002 |
| Study First Received: | July 19, 2005 |
| Last Updated: | December 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00122460 History of Changes |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
|
Head and Neck Cancer |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cetuximab Carboplatin Immunosuppressive Agents Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Head and Neck Neoplasms Fluorouracil Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |