CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1000 mg/m2from 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/NCT00417976
NCT00417976Phase 2Completed
CompareCT.gov

A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

Tony Bekaii-Saab·interventional·Posted Jan 4, 2007·Updated Oct 1, 2015

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Bevacizumab, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 42 participants across 2 sites.

Detailed Summary

This is a phase II study of biweekly (every other week) bevacizumab followed by gemcitabine then infusional 5-fluorouracil in patients with stage III or IV pancreatic cancer. Patients' response will be evaluated every 8 weeks using usual CT scanning techniques. RECIST (Response Evaluation Criteria in Solid tumors) criteria will be applied to evaluate response. Tumor marker levels (Ca 19-9) will be assessed every 4 weeks, but will not be used to measure response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2007
Enrollment StartDec 1, 2006
Primary CompletionMar 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago

Interventions

Gemcitabinedrug

1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumabdrug

10 mg/kg every 2 weeks.

Infusional 5-Fluorouracildrug

2400 mg/m2 over 48 hours every 2 weeks.