CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 442 enrolled
Drug / intervention
Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) +1 moredrug
Likely dose
Cetuximab 400 mg/m² initial dose, then 250 mg/m² weekly IV; Cisplatin 100 mg/m² day 1 OR Carboplatin AUC 5 day 1; 5-FU 1000 mg/m² continuous IV days 1–4, every 3 weeksAI-extracted
Key inclusion· 2
  • ✓Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
  • ✓Recurrent and/or metastatic SCCHN not suitable for local therapy
Key exclusion· 3
  • ✕Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease completed >6 months before study entry
  • ✕Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks before study entry
  • ✕Nasopharyngeal carcinoma

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00122460
NCT00122460Phase 3Completed
CompareCT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Jul 22, 2005·Updated Jul 23, 2014

In Brief

A Phase 3 clinical trial evaluating Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) and Platinum (Cisplatin or Carboplatin) + 5-FU for Head and Neck Cancer. Completed, enrolled 442 participants across 70 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesAustria, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2005
Enrollment StartDec 1, 2004
Primary CompletionMar 1, 2007
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.9 years ago

Interventions

Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)drug

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

Platinum (Cisplatin or Carboplatin) + 5-FUdrug

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