CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
cetuximab +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00305877
NCT00305877Phase 2Completed

An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma

National Cancer Institute (NCI)·interventional·Posted Mar 22, 2006·Updated May 21, 2014

In Brief

A Phase 2 clinical trial evaluating cetuximab, gemcitabine hydrochloride, and 4 other interventions for Stage IA Pancreatic Cancer and 3 related conditions. Completed, enrolled 137 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJul 1, 2008
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.3 years ago

Interventions

cetuximabbiological

Given IV

gemcitabine hydrochloridedrug

Given IV

capecitabinedrug

Given orally

radiation therapyradiation

Undergo radiation therapy

bevacizumabbiological

Given IV

laboratory biomarker analysisother

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