CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Cetuximab +1 moredrug
Likely dose
Cetuximab 400 mg/m² IV initial dose over 120 minutes, then 250 mg/m² IV weekly over 60 minutesAI-extracted
Key inclusion· 7
  • Pathologically confirmed soft tissue sarcoma or bony sarcoma
  • Tumor tissue available for EGFR assessment by immunohistochemistry (IHC)
  • Zubrod performance status 0–2
  • Age 16 years or older
Key exclusion· 6
  • Acute hepatitis or known HIV
  • Active or uncontrolled infection
  • Significant uncontrolled cardiac disease (uncontrolled hypertension, unstable angina, recent MI within 6 months, uncontrolled CHF, cardiomyopathy with decreased EF)
  • Prior therapy targeting the EGFR pathway

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

Search/NCT00148109
NCT00148109Phase 2Completed

Phase II Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas

University of Michigan Rogel Cancer Center·interventional·Posted Sep 7, 2005·Updated Jan 24, 2013

In Brief

A Phase 2 clinical trial evaluating Cetuximab for Sarcoma. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to explore how this cancer is affected by a new medication, cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor receptor), that is found in some types of cancer. Studies have shown that this drug can be beneficial in patients with colon cancer and has been approved by the US Food and Drug Administration (FDA) for this purpose. The researchers are conducting a study to see if it is beneficial in patients with sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartJun 1, 2005
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

Cetuximabdrug

The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes.

Cetuximabdrug

Cetuximab 400 mg/m2 over 120 min IV initial does followed by weekly Cetuximab 250 mg/m2 over 60 min