CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 enrolled
Drug / intervention
cetuximab +3 morebiological
Likely dose
Bevacizumab IV + gemcitabine IV combined with either cetuximab IV or erlotinib orally; specific doses not stated in provided textAI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas with advanced disease
  • Locally advanced disease must extend outside boundaries of standard radiation port
  • Not amenable to curative surgery or radiotherapy
  • Measurable disease: at least 1 unidimensional lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
Key exclusion· 13
  • Prior bevacizumab or cetuximab
  • Prior vascular endothelial growth factor inhibitors
  • Prior gemcitabine
  • Prior erlotinib or other EGFR inhibitors

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

Search/NCT00091026
NCT00091026Phase 2Completed

A Randomized Phase II Study of Bevacizumab (NSC# 704865) and Gemcitabine in Combination With Either Cetuximab (NSC# 714692) or OSI-774 (NSC# 718781) in Patients With Advanced Pancreatic Cancer

National Cancer Institute (NCI)·interventional·Posted Sep 8, 2004·Updated May 15, 2014

In Brief

A Phase 2 clinical trial evaluating cetuximab, gemcitabine hydrochloride, and 2 other interventions for Adenocarcinoma of the Pancreas and 4 related conditions. Completed, enrolled 143 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2004
Enrollment StartJul 1, 2004
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 21.8 years ago

Interventions

cetuximabbiological

Given IV

gemcitabine hydrochloridedrug

Given IV

bevacizumabbiological

Given IV

erlotinib hydrochloridedrug

Given orally