CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
bevacizumab +2 morebiological
Likely dose
Gemcitabine IV 30 minutes on days 1 and 8; Capecitabine twice daily on days 1-14; Bevacizumab 30-90 minutes on day 1; courses repeat every 21 days for up to 12 monthsAI-extracted
Key inclusion· 9
  • Histologically confirmed adenocarcinoma of the pancreas that is newly diagnosed or previously treated metastatic disease, or unresectable disease
  • Age over 18 years
  • ECOG performance status 0-1
  • Life expectancy greater than 3 months
Key exclusion· 7
  • CNS or brain metastases
  • Evidence of bleeding diathesis or coagulopathy
  • Clinically significant grade II-IV peripheral vascular disease
  • Significant traumatic injury within the past 28 days

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

Search/NCT00100815
NCT00100815Phase 2Completed

Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer

Roswell Park Cancer Institute·interventional·Posted Jan 7, 2005·Updated Dec 24, 2015

In Brief

A Phase 2 clinical trial evaluating bevacizumab, capecitabine, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

RATIONALE: 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. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 7, 2005
Enrollment StartAug 1, 2004
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 21.5 years ago

Interventions

bevacizumabbiological

30-90 minutes on day 1, every 21 days up to 12 months.

capecitabinedrug

twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

gemcitabine hydrochloridedrug

IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.