CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
cetuximabbiological
Likely dose
Cetuximab 400 mg/m² IV loading dose over 120 minutes, followed by weekly 250 mg/m² IV over 60 minutesAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed adenocarcinoma of the thoracic esophagus (>20 cm from incisors) or gastroesophageal junction (≤2 cm into gastric cardia)
  • ✓Metastatic disease confined to esophagus and periesophageal soft tissue
  • ✓Measurable disease by imaging or physical examination
  • ✓Exactly one prior chemotherapy regimen for metastatic or recurrent disease (one prior adjuvant or neoadjuvant allowed at initial diagnosis)
Key exclusion· 5
  • ✕Known brain metastases
  • ✕Prior cetuximab or therapy targeting epidermal growth factor pathway
  • ✕Prior allergic reaction to chimerized or murine monoclonal antibodies, or evidence of human anti-mouse antibodies (HAMA)
  • ✕Other malignancy within the past 5 years except adequately treated skin cancers or cervical carcinoma in situ or stage I-II cancer in complete remission

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

Search/NCT00096031
NCT00096031Phase 2Completed
CompareCT.gov

Cetuximab As Second Line Therapy In Patients With Metastatic Esophageal Cancer - Phase II

SWOG Cancer Research Network·interventional·Posted Nov 9, 2004·Updated Sep 26, 2018

In Brief

A Phase 2 clinical trial evaluating cetuximab for Esophageal Cancer. Completed, enrolled 63 participants across 152 sites.

Detailed Summary

RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartOct 1, 2004
Primary CompletionJan 1, 2008
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 21.6 years ago

Interventions

cetuximabbiological

1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.